The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Isatuximab-based Therapy in Participants With Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769181
Recruitment Status : Terminated (Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern)
First Posted : December 7, 2018
Results First Posted : October 17, 2023
Last Update Posted : October 17, 2023
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: isatuximab SAR650984
Drug: cemiplimab REGN2810
Enrollment 58
Recruitment Details Study was conducted at 20 sites in 7 countries. A total of 58 participants were enrolled between 11 December 2018 and 27 August 2020 and received isatuximab in combination with cemiplimab. Study was planned to be conducted in 2 parts: Phase 1(safety run-in) and Phase 2 (efficacy/2-stage design).
Pre-assignment Details Efficacy results observed in Cohorts B & C didn't fulfill preplanned interim analysis criteria allowing the study to move to Phase(Ph) 2 Stage 2 in these cohorts. Efficacy results observed in Cohorts A1 & A2 fulfilled preplanned interim analysis criteria in Stage 1 to move to Ph 2 Stage 2 in these cohorts. However, study was stopped for all cohorts per sponsor's decision. Participant flow, Baseline,outcome measures & safety data were prespecified to be analyzed on combined Ph 1 & 2 populations.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description Classic Hodgkin's lymphoma (cHL), anti-programmed cell death protein 1/ligand 1 (PD-1/PD-L1) inhibitor naïve participants with received isatuximab 10 mg/kg, IV infusion once a week (QW) in Cycle 1 and then every 2 weeks (Q2W) from Cycle 2 to Cycle 6 (each cycle of 28 days), and then every 3 weeks (Q3W) from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable adverse events (AEs) or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of complete response [CR], whichever was longer) of delivery of investigational medicinal product(s) without documented progressive disease (PD), or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). Diffuse large B-cell lymphoma (DLBCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). Peripheral T-cell lymphoma (PTCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Period Title: Overall Study
Started 18 12 17 11
Completed [1] 5 4 0 0
Not Completed 13 8 17 11
Reason Not Completed
Adverse Event             1             0             2             4
Withdrawal by Subject             1             0             2             1
Progressive disease             9             7             13             6
Other - Unspecified             2             1             0             0
[1]
Participants who completed study treatment.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab Total
Hide Arm/Group Description cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). Total of all reporting groups
Overall Number of Baseline Participants 18 12 17 11 58
Hide Baseline Analysis Population Description
Analysis was performed on all treated population which included all participants who signed the study informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 12 participants 17 participants 11 participants 58 participants
44.8  (20.1) 38.0  (15.5) 60.8  (14.2) 65.5  (8.8) 52.0  (18.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 12 participants 17 participants 11 participants 58 participants
Female
8
  44.4%
5
  41.7%
5
  29.4%
4
  36.4%
22
  37.9%
Male
10
  55.6%
7
  58.3%
12
  70.6%
7
  63.6%
36
  62.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 12 participants 17 participants 11 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
1
   8.3%
4
  23.5%
2
  18.2%
8
  13.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
12
  66.7%
4
  33.3%
8
  47.1%
7
  63.6%
31
  53.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  27.8%
7
  58.3%
5
  29.4%
2
  18.2%
19
  32.8%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.
Time Frame Cycle 1 (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on DLT evaluable population which included all participants who received the planned doses of isatuximab and cemiplimab during Cycle 1 and completed the DLT observation period after the first administration of the study drug. Here, "0" in the "overall number of participants analyzed" signifies that no participants were evaluable for DLTs in the Cohort A1 arm.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 0 1 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study treatment up to 30 days after the last dose of study treatment).
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population which included all participants who signed the informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
16
  88.9%
12
 100.0%
17
 100.0%
11
 100.0%
TESAEs
3
  16.7%
2
  16.7%
10
  58.8%
7
  63.6%
3.Primary Outcome
Title Number of Participants With Laboratory Abnormalities: Hematological Parameters
Hide Description Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia: Grade 1
9
  50.0%
6
  50.0%
7
  41.2%
6
  54.5%
Anemia: Grade 2
5
  27.8%
1
   8.3%
7
  41.2%
3
  27.3%
Anemia: Grade 3
2
  11.1%
0
   0.0%
2
  11.8%
2
  18.2%
Anemia: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cell decreased: Grade 1
10
  55.6%
2
  16.7%
9
  52.9%
3
  27.3%
White blood cell decreased: Grade 2
1
   5.6%
1
   8.3%
2
  11.8%
4
  36.4%
White blood cell decreased: Grade 3
0
   0.0%
0
   0.0%
1
   5.9%
2
  18.2%
White blood cell decreased: Grade 4
0
   0.0%
0
   0.0%
2
  11.8%
0
   0.0%
Platelet count decreased: Grade 1
8
  44.4%
3
  25.0%
7
  41.2%
3
  27.3%
Platelet count decreased: Grade 2
0
   0.0%
0
   0.0%
2
  11.8%
1
   9.1%
Platelet count decreased: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
Platelet count decreased: Grade 4
0
   0.0%
0
   0.0%
2
  11.8%
3
  27.3%
Lymphocyte count decreased: Grade 1
4
  22.2%
2
  16.7%
2
  11.8%
0
   0.0%
Lymphocyte count decreased: Grade 2
3
  16.7%
0
   0.0%
4
  23.5%
6
  54.5%
Lymphocyte count decreased: Grade 3
5
  27.8%
1
   8.3%
6
  35.3%
3
  27.3%
Lymphocyte count decreased: Grade 4
1
   5.6%
0
   0.0%
2
  11.8%
1
   9.1%
Neutrophil count decreased: Grade 1
0
   0.0%
0
   0.0%
2
  11.8%
2
  18.2%
Neutrophil count decreased: Grade 2
3
  16.7%
0
   0.0%
2
  11.8%
2
  18.2%
Neutrophil count decreased: Grade 3
0
   0.0%
0
   0.0%
1
   5.9%
1
   9.1%
Neutrophil count decreased: Grade 4
0
   0.0%
0
   0.0%
2
  11.8%
2
  18.2%
4.Primary Outcome
Title Number of Participants With Laboratory Abnormalities: Electrolytes
Hide Description Electrolyte parameters assessed were hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Abnormal criteria was assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. Here "number analyzed" signifies the participants with available data for each specified parameter.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants with received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Count of Participants
Unit of Measure: Participants
Hyponatremia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
8
  44.4%
4
  33.3%
6
  35.3%
5
  45.5%
Hyponatremia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyponatremia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
2
  11.8%
3
  27.3%
Hyponatremia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypokalemia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypokalemia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
3
  16.7%
3
  25.0%
3
  17.6%
5
  45.5%
Hypokalemia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
3
  17.6%
0
   0.0%
Hypokalemia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperkalemia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
1
   5.6%
2
  16.7%
2
  11.8%
1
   9.1%
Hyperkalemia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
1
   5.6%
0
   0.0%
0
   0.0%
1
   9.1%
Hyperkalemia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
Hyperkalemia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia: Grade 1 Number Analyzed 5 participants 6 participants 4 participants 3 participants
1
  20.0%
0
   0.0%
1
  25.0%
1
  33.3%
Hypocalcemia: Grade 2 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia: Grade 3 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia: Grade 4 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoalbuminemia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
3
  16.7%
2
  16.7%
5
  29.4%
2
  18.2%
Hypoalbuminemia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
4
  22.2%
0
   0.0%
6
  35.3%
5
  45.5%
Hypoalbuminemia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
Hypoalbuminemia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoglycemia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
5
  27.8%
1
   8.3%
0
   0.0%
1
   9.1%
Hypoglycemia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
Hypoglycemia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypoglycemia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperglycemia: Grade 1 Number Analyzed 18 participants 12 participants 17 participants 11 participants
2
  11.1%
5
  41.7%
1
   5.9%
6
  54.5%
Hyperglycemia: Grade 2 Number Analyzed 18 participants 12 participants 17 participants 11 participants
2
  11.1%
2
  16.7%
3
  17.6%
2
  18.2%
Hyperglycemia: Grade 3 Number Analyzed 18 participants 12 participants 17 participants 11 participants
2
  11.1%
0
   0.0%
1
   5.9%
0
   0.0%
Hyperglycemia: Grade 4 Number Analyzed 18 participants 12 participants 17 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypercalcemia: Grade 1 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypercalcemia: Grade 2 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypercalcemia: Grade 3 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Hypercalcemia: Grade 4 Number Analyzed 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Laboratory Abnormalities: Renal Parameters
Hide Description Abnormal renal parameters assessed were glomerular filtration rate (GFR) by class, creatinine increased and hyperuricemia. GFR by class was assessed in categories:>=90 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) (Normal), >=60 to <90 mL/min/1.73m^2 (Mild), >=30 to <60 mL/min/1.73m^2 (Moderate), >=15 to <30 mL/min/1.73m^2 (Severe), and <15 mL/min/1.73m^2 (End Stage Renal Disease). Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Count of Participants
Unit of Measure: Participants
GFR: >=90 mL/min/1.73m^2
7
  38.9%
2
  16.7%
4
  23.5%
1
   9.1%
GFR: >=60 to <90 mL/min/1.73m^2
8
  44.4%
8
  66.7%
8
  47.1%
7
  63.6%
GFR: >=30 to <60 mL/min/1.73m^2
3
  16.7%
2
  16.7%
4
  23.5%
2
  18.2%
GFR: >=15 to <30 mL/min/1.73m^2
0
   0.0%
0
   0.0%
1
   5.9%
1
   9.1%
GFR: <15 mL/min/1.73m^2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine increased: Grade 1
2
  11.1%
3
  25.0%
4
  23.5%
1
   9.1%
Creatinine increased: Grade 2
3
  16.7%
1
   8.3%
3
  17.6%
4
  36.4%
Creatinine increased: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine increased: Garde 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperuricemia: Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperuricemia: Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperuricemia: Grade 3
1
   5.6%
3
  25.0%
5
  29.4%
2
  18.2%
Hyperuricemia: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Laboratory Abnormalities: Liver Function Parameters
Hide Description Abnormal liver function parameters assessed were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Count of Participants
Unit of Measure: Participants
AST increased: Grade 1
3
  16.7%
2
  16.7%
5
  29.4%
3
  27.3%
AST increased: Grade 2
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
AST increased: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST increased: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT increased: Grade 1
1
   5.6%
7
  58.3%
6
  35.3%
0
   0.0%
ALT increased: Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT increased: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT increased: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP increased: Grade 1
3
  16.7%
5
  41.7%
4
  23.5%
5
  45.5%
ALP increased: Grade 2
2
  11.1%
0
   0.0%
2
  11.8%
0
   0.0%
ALP increased: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP increased: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BB increased: Grade 1
1
   5.6%
0
   0.0%
1
   5.9%
2
  18.2%
BB increased: Grade 2
0
   0.0%
0
   0.0%
2
  11.8%
1
   9.1%
BB increased: Grade 3
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
BB increased: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Cohort A1: Percentage of Participants With Complete Response (CR)
Hide Description Percentage of participants who had a CR as a best overall response (BOR) using the Lugano response criteria (LRC) 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT response was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative.
Time Frame From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified in protocol.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
27.8
8.Primary Outcome
Title Cohort A2, B and C: Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants who had a CR or partial response (PR) as BOR using LRC, 2014. Per LRC, CR (PET-CT): complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (PET-CT): partial MR in lymph nodes and extralymphatic sites; no new lesions and residual uptake higher than uptake. PR (Per CT): lymph nodes, extralymphatic sites>=50% decrease in sum of product of perpendicular diameters (SPD), extranodal sites; if lesion is too small to measure on CT,assign5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions.
Time Frame From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population.
Arm/Group Title Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 12 17 11
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(12.3 to 60.9)
5.9
(0.3 to 25.0)
9.1
(0.5 to 36.4)
9.Secondary Outcome
Title Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab
Hide Description ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Anti-drug antibody (ADA) evaluable population that included all participants who signed informed consent and received at least 1 dose of either isatuximab or cemiplimab, with at least 1 non-missing ADA result after the drug administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-Induced ADA
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Treatment-Boosted ADA
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab
Hide Description ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.
Time Frame From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ADA evaluable population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 11 10 6
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-Induced ADA
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
Treatment-Boosted ADA
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)
Hide Description Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.
Time Frame End of infusion (EOI up to 3 hours) on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab) which included participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (isatuximab) administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
221  (47.2) 263  (39.4) 235  (39.3) 181  (35.7)
12.Secondary Outcome
Title PK Parameter: Maximum Observed Plasma Concentration (Cmax) After the First Infusion of Isatuximab
Hide Description Cmax was defined as the maximum plasma concentration observed after the first administration of drug.
Time Frame At Start of infusion (SOI; 0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Mean (Standard Deviation)
Unit of Measure: mcg/mL
226  (48.1) 265  (38.8) 253  (29.1) 181  (35.7)
13.Secondary Outcome
Title PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Isatuximab
Hide Description Tmax was defined as the time to reach Cmax, after the intravenous infusion of isatuximab.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Median (Full Range)
Unit of Measure: hours
5.95
(2.00 to 8.92)
5.23
(3.00 to 8.83)
5.26
(2.60 to 10.5)
4.57
(2.33 to 7.45)
14.Secondary Outcome
Title PK Parameter: Area Under the Plasma Concentration (AUClast) Versus Time Curve After the First Infusion of Isatuximab
Hide Description AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration, calculated for isatuximab.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Mean (Standard Deviation)
Unit of Measure: hours*mcg/mL
20400  (5190) 22700  (6020) 21700  (4610) 14400  (4710)
15.Secondary Outcome
Title PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab
Hide Description Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Mean (Standard Deviation)
Unit of Measure: mcg/mL
93.3  (28.1) 110  (24.5) 89.8  (24.7) 40.4  (17.7)
16.Secondary Outcome
Title PK Parameter: Time of Clast (Tlast) After the First Infusion of Isatuximab
Hide Description Tlast was defined as the time of last concentration observed above the lower limit of quantification for isatuximab.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 12 14 7
Median (Full Range)
Unit of Measure: hours
142
(136 to 174)
143
(72.6 to 167)
143
(137 to 147)
144
(142 to 169)
17.Secondary Outcome
Title PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-168 Hours) After the First Infusion of Isatuximab
Hide Description AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated for isatuximab. Samples for this outcome measure were collected up to 144 hours post-dose. No sample was collected at 168 hours post-dose; and thus, the samples collected up to 144 hours post-dose were extrapolated to derive data for 168 hours post-dose.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 11 14 7
Mean (Standard Deviation)
Unit of Measure: hour*mcg/mL
22500  (5770) 26600  (4030) 23700  (4960) 15000  (4680)
18.Secondary Outcome
Title PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-144 Hours) After the First Infusion of Isatuximab
Hide Description AUC0-144 hours was defined as the area under the plasma concentration versus time curve from time 0 to 144 hours post dose calculated for isatuximab.
Time Frame At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 11 14 7
Mean (Standard Deviation)
Unit of Measure: hours*mcg/mL
20400  (5170) 24300  (3470) 21800  (4550) 14000  (4240)
19.Secondary Outcome
Title PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab
Hide Description Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing.
Time Frame Pre-infusion on Cycle1:Day 2, 8, 15, & 22, Cycle 2:Day 1 &15, Cycle 3:Day 1 &15, Cycle 4:Day 1 &15, Cycle 5 Day1,Cycle 6 Day1,Cycle 7 Day 1, Cycle 8 Day1, Cycle 9 Day1, Cycle 10 Day1, Cycle 11 Day1, Cycle14 Day1, Cycle 17 Day1, Cycle 20 Day1,Cycle 23 Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for isatuximab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoints.
Arm/Group Title Cohort A1: cHL: Isatuximab Cohort A2: cHL: Isatuximab Cohort B: DLBCL: Isatuximab Cohort C: PTCL: Isatuximab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 16 9
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1 Day 2 Number Analyzed 18 participants 12 participants 15 participants 9 participants
0  (0) 0  (0) 0  (0) 0  (0)
Cycle 1 Day 8 Number Analyzed 17 participants 10 participants 15 participants 8 participants
93.1  (28.1) 98.4  (39.5) 93.2  (27.2) 37.7  (18.0)
Cycle 1 Day 15 Number Analyzed 16 participants 8 participants 10 participants 6 participants
159  (47.7) 191  (41.4) 181  (43.7) 115  (89.4)
Cycle 1 Day 22 Number Analyzed 13 participants 12 participants 9 participants 5 participants
254  (59.8) 262  (45.2) 259  (57.9) 124  (22.9)
Cycle 2 Day 1 Number Analyzed 15 participants 9 participants 5 participants 4 participants
310  (78.2) 352  (48.7) 316  (110) 132  (64.0)
Cycle 2 Day 15 Number Analyzed 15 participants 10 participants 5 participants 5 participants
314  (141) 390  (256) 291  (108) 129  (59.1)
Cycle 3 Day 1 Number Analyzed 17 participants 10 participants 5 participants 5 participants
304  (79.8) 320  (49.7) 327  (92.4) 122  (58.0)
Cycle 3 Day 15 Number Analyzed 15 participants 11 participants 3 participants 3 participants
325  (85.1) 336  (42.3) 420  (67.8) 176  (8.19)
Cycle 4 Day 1 Number Analyzed 14 participants 11 participants 2 participants 4 participants
334  (91.8) 344  (58.2) 350  (80.6) 149  (33.2)
Cycle 4 Day 15 Number Analyzed 15 participants 9 participants 2 participants 3 participants
363  (122) 376  (65.2) 336  (117) 158  (16.9)
Cycle 5 Day 1 Number Analyzed 13 participants 10 participants 1 participants 3 participants
385  (79.9) 383  (71.0) 362 157  (11.5)
Cycle 6 Day 1 Number Analyzed 11 participants 7 participants 1 participants 1 participants
379  (105) 361  (97.8) 415 137
Cycle 7 Day 1 Number Analyzed 9 participants 8 participants 0 participants 1 participants
408  (141) 374  (107) 186
Cycle 8 Day 1 Number Analyzed 9 participants 6 participants 1 participants 0 participants
352  (94.9) 356  (57.7) 360
Cycle 9 Day 1 Number Analyzed 8 participants 6 participants 0 participants 1 participants
328  (124) 351  (54.8) 83.5
Cycle 10 Day 1 Number Analyzed 7 participants 5 participants 1 participants 0 participants
317  (120) 347  (51.8) 383
Cycle 11 Day 1 Number Analyzed 5 participants 5 participants 0 participants 0 participants
318  (147) 357  (52.0)
Cycle 14 Day 1 Number Analyzed 3 participants 5 participants 0 participants 0 participants
357  (119) 333  (28.0)
Cycle 17 Day 1 Number Analyzed 0 participants 5 participants 0 participants 0 participants
299  (22.3)
Cycle 20 Day 1 Number Analyzed 1 participants 4 participants 0 participants 0 participants
117 328  (14.4)
Cycle 23 Day 1 Number Analyzed 0 participants 2 participants 0 participants 0 participants
309  (9.90)
20.Secondary Outcome
Title PK Parameter: Serum Concentration of Cemiplimab at End of Infusion (CEOI)
Hide Description Ceoi is the plasma concentration observed at the end of intravenous infusion of cemiplimab.
Time Frame EOI (up to 30 minutes [min]) on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab) which included all participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (cemiplimab) administration. Here 'overall number of participants analyzed" signifies the participants evaluable for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Mean (Standard Deviation)
Unit of Measure: milligrams per milliliter (mg/mL)
63.7  (24.2) 78.8  (24.9) 68.1  (26.3) 66.2  (18.4)
21.Secondary Outcome
Title PK Parameter: Maximum Observed Concentration (Cmax) After the First Infusion of Cemiplimab
Hide Description Cmax was defined as the maximum concentration observed after the first administration.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Mean (Standard Deviation)
Unit of Measure: mg/L
70.9  (21.1) 90.8  (19.4) 79.0  (16.7) 77.1  (20.7)
22.Secondary Outcome
Title PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Cemiplimab
Hide Description Tmax was defined as the time to reach Cmax after the intravenous infusion of cemiplimab.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Median (Full Range)
Unit of Measure: hours
4.00
(0.480 to 4.67)
4.50
(0.480 to 4.53)
4.05
(0.420 to 5.40)
2.34
(0.500 to 4.08)
23.Secondary Outcome
Title PK Parameter: Area Under the Serum Concentration (AUClast) Versus Time Curve After the First Infusion of Cemiplimab
Hide Description AUClast was defined as area under the serum concentration versus time curve calculated from time 0 to last quantifiable concentration calculated for cemiplimab.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Mean (Standard Deviation)
Unit of Measure: day*mg/mL
524  (188) 648  (112) 506  (159) 466  (147)
24.Secondary Outcome
Title PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Cemiplimab
Hide Description Clast was defined as the last concentration of cemiplimab observed above the lower limit of quantification.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Mean (Standard Deviation)
Unit of Measure: mg/L
23.4  (11.2) 30.3  (7.16) 27.0  (9.79) 14.3  (6.64)
25.Secondary Outcome
Title PK Parameter: Time of Clast (Tlast) After the First Infusion of Cemiplimab
Hide Description Tlast was defined as the time of last concentration observed above the lower limit of quantification for cemiplimab.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants analyzed" signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Median (Full Range)
Unit of Measure: hours
334
(164 to 672)
333
(330 to 362)
332
(164 to 339)
335
(171 to 572)
26.Secondary Outcome
Title PK Parameter: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUC0-336 Hours) After the First Infusion of Cemiplimab
Hide Description AUC0-336 hours was defined as the area under the serum concentration versus time curve from time 0 to 336 hours post dose for cemiplimab.
Time Frame At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 17 5 15 8
Mean (Standard Deviation)
Unit of Measure: day*mg/mL
519  (177) 645  (113) 546  (136) 466  (130)
27.Secondary Outcome
Title PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab
Hide Description Ctrough was the serum concentration of cemiplimab observed just before treatment administration during repeated dosing.
Time Frame Pre-infusion on Cycle 1:Day 1 & Day15,Cycle 2:Day 1 & Day 15,Cycle 3:Day 1 & Day 15,Cycle 4:Day 1 & Day15,Cycle 5 Day 1,Cycle 6 Day 1,Cycle7 Day1,Cycle 8 Day 1,Cycle 9 Day1,Cycle 10 Day1,Cycle11 Day1,Cycle14 Day 1,Cycle 17 Day1,Cycle20 Day 1,Cycle 23 Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for Cemiplimab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoint.
Arm/Group Title Cohort A1: cHL: Cemiplimab Cohort A2: cHL: Cemiplimab Cohort B: DLBCL: Cemiplimab Cohort C: PTCL: Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Mean (Standard Deviation)
Unit of Measure: mg/mL
Cycle 1 Day 1 Number Analyzed 17 participants 5 participants 17 participants 11 participants
0.00800  (0.0330) 0.980  (2.19) 0  (0) 0  (0)
Cycle 1 Day 15 Number Analyzed 14 participants 5 participants 12 participants 6 participants
25.3  (10.2) 30.3  (7.16) 24.2  (9.91) 16.5  (4.83)
Cycle 2 Day 1 Number Analyzed 14 participants 5 participants 5 participants 4 participants
44.1  (11.2) 51.1  (15.8) 49.6  (16.3) 33.0  (10.4)
Cycle 2 Day 15 Number Analyzed 14 participants 4 participants 5 participants 5 participants
64.4  (22.5) 61.0  (10.8) 48.9  (9.16) 38.3  (21.1)
Cycle 3 Day 1 Number Analyzed 16 participants 5 participants 5 participants 5 participants
77.7  (30.2) 73.7  (11.0) 62.8  (13.6) 66.7  (64.7)
Cycle 3 Day 15 Number Analyzed 13 participants 5 participants 3 participants 3 participants
95.1  (35.0) 86.6  (19.5) 72.3  (3.80) 72.1  (12.1)
Cycle 4 Day 1 Number Analyzed 13 participants 5 participants 2 participants 4 participants
100  (38.9) 84.4  (20.3) 76.8  (4.31) 66.7  (24.1)
Cycle 4 Day 15 Number Analyzed 13 participants 4 participants 2 participants 3 participants
113  (44.8) 88.2  (30.5) 91.6  (10.3) 63.5  (24.8)
Cycle 5 Day 1 Number Analyzed 12 participants 4 participants 1 participants 3 participants
106  (28.9) 92.7  (21.8) 91.6 73.4  (26.5)
Cycle 6 Day 1 Number Analyzed 10 participants 4 participants 1 participants 1 participants
114  (37.3) 94.8  (29.8) 113 73.8
Cycle 7 Day 1 Number Analyzed 8 participants 5 participants 0 participants 1 participants
112  (32.6) 115  (43.0) 100
Cycle 8 Day 1 Number Analyzed 9 participants 3 participants 1 participants 0 participants
110  (40.5) 129  (19.5) 93.0
Cycle 9 Day 1 Number Analyzed 7 participants 3 participants 1 participants 1 participants
107  (36.2) 122  (27.9) 122 61.8
Cycle 10 Day 1 Number Analyzed 7 participants 3 participants 1 participants 0 participants
112  (65.8) 139  (23.2) 122
Cycle 11 Day 1 Number Analyzed 6 participants 4 participants 0 participants 0 participants
120  (60.2) 133  (14.5)
Cycle 14 Day 1 Number Analyzed 3 participants 4 participants 0 participants 0 participants
138  (72.7) 127  (17.1)
Cycle 17 Day 1 Number Analyzed 1 participants 4 participants 0 participants 0 participants
60.6 131  (18.8)
Cycle 20 Day 1 Number Analyzed 1 participants 3 participants 0 participants 0 participants
62.6 137  (26.7)
Cycle 23 Day 1 Number Analyzed 0 participants 1 participants 0 participants 0 participants
137
28.Secondary Outcome
Title Percent Change From Baseline in Tumor Burden
Hide Description Tumor burden change was defined as the best percent-change from baseline in a sum of product of lesion diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions.
Time Frame Up to 103 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 10 8 6
Mean (Standard Deviation)
Unit of Measure: percent change
-48.8  (59.0) -55.3  (32.6) 396.0  (880.7) -9.7  (87.8)
29.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Time (months) between date of first response to first date that recurrent or radiologically disease progression (PD) was documented, or date of death,whichever was 1st. In absence of PD or death before cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response not showing PD performed prior to initiation of further anticancer treatment or cut-off date, whichever was earlier. PD(PET-CT): metabolic disease with score 4/5 with inc. in intensity of uptake for target nodes/nodal mass & new FDG-avid foci consistent with lymphoma. PD(CT):any 1 of following: cross product of longest transverse diameter of lesion(LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi(SDi) from nadir 0.5 cm, regrowth of resolved lesions, new splenomegaly,progression of non-measured lesion, new/recurrent involvement of bone marrow.
Time Frame From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on participants who had a response. DOR was analyzed using Kaplan-Meier method. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 10 4 1 1
Mean (Standard Deviation)
Unit of Measure: months
5.8  (5.2) 7.3  (4.8) 17.1 14.0
30.Secondary Outcome
Title Percentage of Participants With Disease Control (DC)
Hide Description DC defined as percentage of participants who achieved CR, PR or stable disease (SD) as per LRC, 2014. CR (PET-CT): complete MR in lymph nodes and extralymphatic sites; no new lesions and no evidence of FDG-avid disease. CR (CT): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow. PR (PET-CT): partial MR in lymph nodes and sites; no new lesions. PR (CT): lymph nodes, sites>=50% decrease in SPD, sites; if lesion is too small to measure on CT, assign 5mm*5mm; No longer visible:0*0mm; Node>5mm*5mm, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. SD (PET-CT):no metabolic response, target nodes score of 4/5 with no significant change & no new lesions; SD (CT): <50% dec in SPD, no increase in progression for. 5PS:1: non-measured lesions, organ enlargement & no new lesions.
Time Frame From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
61.1
(39.2 to 80.1)
58.3
(31.5 to 81.9)
5.9
(0.3 to 25.0)
18.2
(3.3 to 47.0)
31.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS: time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever occurs 1st. Per LRC, 2014 PD (per PET-CT): metabolic disease with score 4/5 with increase (inc) in intensity of uptake for individual target nodes/nodal mass & new FDG-avid foci consistent with lymphoma at interim/ end-of-treatment assessment for extra nodal lesions, new FDG-avid foci consistent with lymphoma rather; new/recurrent FDG-avid foci bone marrow. PD (per CT response): any 1 of following: cross product of longest transverse diameter of lesion (LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi from nadir 0.5 cm for lesion <= 2 cm, regrowth of resolved lesions, new splenomegaly,progression of preexisting non measured lesion, new/recurrent involvement of bone marrow.
Time Frame From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. PFS was analyzed using Kaplan-Meier method.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12 17 11
Median (95% Confidence Interval)
Unit of Measure: months
5.09
(2.694 to 13.207)
6.21
(2.595 to 10.349)
2.37
(0.460 to 2.694)
2.66
(0.427 to 6.341)
32.Secondary Outcome
Title Cohort A1 and A2: Percentage of Participants With Objective Response
Hide Description Percentage of participants who had a CR or PR as BOR using LRC, 2014 (based on PET-CT and CT responses). CR (per PET-CT): complete MR in lymph nodes and extra lymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (per PET-CT): partial MR in lymph nodes and extral ymphatic sites; no new lesions and residual uptake higher than uptake. PR (per CT): lymph nodes, extralymphatic sites >=50% decrease in SPD, extranodal sites; if lesion is too small to measure on CT, assign 5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, used actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions.
Time Frame From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. Data for cohort B and C are reported separately.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
55.6
(34.1 to 75.6)
33.3
(12.3 to 60.9)
33.Secondary Outcome
Title Cohort A1 and A2: Percentage of Participants With Complete Response
Hide Description Percentage of participants who had a CR as a BOR using the LRC, 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative.
Time Frame From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified.
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab
Hide Arm/Group Description:
cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Number of Participants Analyzed 18 12
Measure Type: Number
Unit of Measure: percentage of participants
27.8 16.7
Time Frame From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks)
Adverse Event Reporting Description Analysis was performed on all-treated population.
 
Arm/Group Title Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Hide Arm/Group Description cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
All-Cause Mortality
Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/18 (22.22%)      0/12 (0.00%)      12/17 (70.59%)      6/11 (54.55%)    
Hide Serious Adverse Events
Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      2/12 (16.67%)      10/17 (58.82%)      7/11 (63.64%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Febrile Neutropenia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Eye disorders         
Visual Acuity Reduced † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Abdominal Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Gastrointestinal Haemorrhage † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Haematemesis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Intestinal Perforation † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Large Intestinal Obstruction † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
General disorders         
Death † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Disease Progression † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  2 0/11 (0.00%)  0
Multiple Organ Dysfunction Syndrome † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Performance Status Decreased † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Pyrexia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations         
Epstein-Barr Virus Infection † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Herpes Zoster Disseminated † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Meningitis Aseptic † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Pneumonia Bacterial † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Pneumonia Haemophilus † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Pneumonia Respiratory Syncytial Viral † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Streptococcal Sepsis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Urinary Tract Infection † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Urinary Tract Infection Bacterial † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  2 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Infusion Related Reaction † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Investigations         
Platelet Count Decreased † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Metabolism and nutrition disorders         
Decreased Appetite † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Hypercalcaemia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate Cancer Metastatic † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders         
Peripheral Sensorimotor Neuropathy † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Pneumonitis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Vascular disorders         
Subclavian Vein Thrombosis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
1
Term from vocabulary, MedDra 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A1: cHL: Isatuximab + Cemiplimab Cohort A2: cHL: Isatuximab + Cemiplimab Cohort B: DLBCL: Isatuximab + Cemiplimab Cohort C: PTCL: Isatuximab + Cemiplimab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/18 (88.89%)      12/12 (100.00%)      17/17 (100.00%)      10/11 (90.91%)    
Blood and lymphatic system disorders         
Febrile Neutropenia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  2 0/11 (0.00%)  0
Neutropenia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Thrombocytopenia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  2 0/11 (0.00%)  0
Cardiac disorders         
Atrial Fibrillation † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Extrasystoles † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Sinus Tachycardia † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Supraventricular Tachycardia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Tachycardia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  2 0/11 (0.00%)  0
Congenital, familial and genetic disorders         
Hypertrophic Cardiomyopathy † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Ear and labyrinth disorders         
Deafness † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Ear Pruritus † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Hypoacusis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Eye disorders         
Conjunctival Oedema † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Vision Blurred † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Abdominal Distension † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Abdominal Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 4/17 (23.53%)  4 0/11 (0.00%)  0
Abdominal Pain Upper † 1  2/18 (11.11%)  2 1/12 (8.33%)  1 1/17 (5.88%)  2 0/11 (0.00%)  0
Aphthous Ulcer † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Ascites † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Constipation † 1  1/18 (5.56%)  1 2/12 (16.67%)  2 1/17 (5.88%)  1 0/11 (0.00%)  0
Diarrhoea † 1  4/18 (22.22%)  6 4/12 (33.33%)  4 4/17 (23.53%)  6 2/11 (18.18%)  2
Dysphagia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Epigastric Discomfort † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  2 0/11 (0.00%)  0
Gastrooesophageal Reflux Disease † 1  0/18 (0.00%)  0 2/12 (16.67%)  2 1/17 (5.88%)  1 0/11 (0.00%)  0
Haemorrhoids † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Melaena † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Nausea † 1  1/18 (5.56%)  1 6/12 (50.00%)  6 4/17 (23.53%)  5 1/11 (9.09%)  1
Oral Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Rectal Haemorrhage † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Vomiting † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 1/17 (5.88%)  1 0/11 (0.00%)  0
General disorders         
Administration Site Extravasation † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Asthenia † 1  3/18 (16.67%)  4 0/12 (0.00%)  0 3/17 (17.65%)  3 1/11 (9.09%)  2
Chills † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  3 0/11 (0.00%)  0
Fatigue † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 4/17 (23.53%)  5 2/11 (18.18%)  2
Generalised Oedema † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Malaise † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Non-Cardiac Chest Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Oedema Peripheral † 1  3/18 (16.67%)  3 0/12 (0.00%)  0 5/17 (29.41%)  5 1/11 (9.09%)  1
Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Pyrexia † 1  4/18 (22.22%)  7 3/12 (25.00%)  3 3/17 (17.65%)  3 3/11 (27.27%)  3
Swelling Face † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Hepatobiliary disorders         
Granulomatous Liver Disease † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Immune system disorders         
Hypogammaglobulinaemia † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Infections and infestations         
Bacteraemia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Bacterial Diarrhoea † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Bronchitis † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 0/17 (0.00%)  0 1/11 (9.09%)  1
Covid-19 † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Cellulitis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Cystitis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Device Related Infection † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Erysipelas † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Fungal Skin Infection † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Genital Herpes † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Herpes Simplex † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Herpes Zoster † 1  1/18 (5.56%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Influenza † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Lower Respiratory Tract Infection † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Nasopharyngitis † 1  0/18 (0.00%)  0 2/12 (16.67%)  2 0/17 (0.00%)  0 0/11 (0.00%)  0
Oral Candidiasis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Oral Herpes † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 1/17 (5.88%)  1 0/11 (0.00%)  0
Pharyngitis † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 0/17 (0.00%)  0 1/11 (9.09%)  1
Pneumonia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Pneumonia Staphylococcal † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Postoperative Wound Infection † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Respiratory Tract Infection † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Rhinitis † 1  1/18 (5.56%)  1 2/12 (16.67%)  3 0/17 (0.00%)  0 0/11 (0.00%)  0
Stenotrophomonas Infection † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Tinea Cruris † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Tonsillitis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Tooth Infection † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Tracheobronchitis † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Trichophytosis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Upper Respiratory Tract Infection † 1  0/18 (0.00%)  0 3/12 (25.00%)  6 1/17 (5.88%)  1 1/11 (9.09%)  1
Urinary Tract Infection † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  2 0/11 (0.00%)  0
Vascular Device Infection † 1  1/18 (5.56%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Viral Infection † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Viral Pharyngitis † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod Bite † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Eye Injury † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Fall † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Infusion Related Reaction † 1  7/18 (38.89%)  11 9/12 (75.00%)  17 8/17 (47.06%)  8 7/11 (63.64%)  8
Limb Traumatic Amputation † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Tibia Fracture † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Investigations         
Gamma-Glutamyltransferase Increased † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Platelet Count Decreased † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Weight Decreased † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Weight Increased † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Metabolism and nutrition disorders         
Decreased Appetite † 1  2/18 (11.11%)  2 0/12 (0.00%)  0 3/17 (17.65%)  3 0/11 (0.00%)  0
Hypoalbuminaemia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Back Pain † 1  4/18 (22.22%)  5 1/12 (8.33%)  1 2/17 (11.76%)  2 0/11 (0.00%)  0
Fibromyalgia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Flank Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  3 0/11 (0.00%)  0
Muscle Spasms † 1  0/18 (0.00%)  0 1/12 (8.33%)  2 0/17 (0.00%)  0 0/11 (0.00%)  0
Muscle Tightness † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal Pain † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Myalgia † 1  2/18 (11.11%)  2 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Neck Pain † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Pain In Extremity † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour Associated Fever † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Tumour Haemorrhage † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Nervous system disorders         
Dizziness † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 1/17 (5.88%)  1 1/11 (9.09%)  1
Headache † 1  2/18 (11.11%)  3 2/12 (16.67%)  2 0/17 (0.00%)  0 1/11 (9.09%)  5
Hypoaesthesia † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Memory Impairment † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Paraesthesia † 1  1/18 (5.56%)  1 1/12 (8.33%)  1 1/17 (5.88%)  1 1/11 (9.09%)  1
Radiculopathy † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Sciatica † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Sedation † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Tremor † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Psychiatric disorders         
Depression † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Insomnia † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 1/17 (5.88%)  1 2/11 (18.18%)  2
Nervousness † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Renal and urinary disorders         
Dysuria † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 2/17 (11.76%)  3 0/11 (0.00%)  0
Haematuria † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Pollakiuria † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Reproductive system and breast disorders         
Haematospermia † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Catarrh † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Cough † 1  2/18 (11.11%)  2 2/12 (16.67%)  2 1/17 (5.88%)  1 0/11 (0.00%)  0
Dyspnoea † 1  2/18 (11.11%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Dyspnoea Exertional † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Epistaxis † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Hiccups † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 2/17 (11.76%)  3 0/11 (0.00%)  0
Interstitial Lung Disease † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Nasal Discharge Discolouration † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Oropharyngeal Pain † 1  1/18 (5.56%)  2 0/12 (0.00%)  0 1/17 (5.88%)  1 1/11 (9.09%)  1
Pleural Effusion † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Productive Cough † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 1/17 (5.88%)  1 0/11 (0.00%)  0
Rhinitis Allergic † 1  2/18 (11.11%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Rhinorrhoea † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders         
Butterfly Rash † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Dermatitis † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Dermatitis Atopic † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 0/11 (0.00%)  0
Drug Eruption † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Eczema † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  2 0/11 (0.00%)  0
Erythema † 1  2/18 (11.11%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  2
Hyperhidrosis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 1/17 (5.88%)  1 0/11 (0.00%)  0
Milia † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Night Sweats † 1  2/18 (11.11%)  2 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Pruritus † 1  2/18 (11.11%)  2 3/12 (25.00%)  3 0/17 (0.00%)  0 1/11 (9.09%)  1
Rash † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Rash Macular † 1  0/18 (0.00%)  0 1/12 (8.33%)  1 0/17 (0.00%)  0 1/11 (9.09%)  1
Rash Maculo-Papular † 1  1/18 (5.56%)  1 1/12 (8.33%)  2 0/17 (0.00%)  0 0/11 (0.00%)  0
Rash Papular † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Vascular disorders         
Hypertension † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
Hypotension † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 3/17 (17.65%)  3 0/11 (0.00%)  0
Lymphorrhoea † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Phlebitis † 1  1/18 (5.56%)  1 0/12 (0.00%)  0 0/17 (0.00%)  0 0/11 (0.00%)  0
Varicophlebitis † 1  0/18 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDra 25.0
†
Indicates events were collected by systematic assessment
The efficacy results observed in Cohorts B and C did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these cohorts. The efficacy results observed in Cohort A1 and A2 fulfilled the pre-planned interim analysis criteria in Stage 1 to move to Phase 2 Stage 2 in these cohorts. However, the study was stopped for all the cohorts as per Sponsor's decision.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi Aventis Recherche & Développement
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Publications:
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03769181    
Other Study ID Numbers: ACT15320
2018-002442-37 ( EudraCT Number )
U1111-1211-9010 ( Registry Identifier: ICTRP )
First Submitted: November 29, 2018
First Posted: December 7, 2018
Results First Submitted: August 15, 2023
Results First Posted: October 17, 2023
Last Update Posted: October 17, 2023