HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT04619004
• Recruitment Status: Active, not recruiting
• First Posted: November 6, 2020
• Results First Posted: April 2, 2024
• Last Update Posted: April 2, 2024
• Sponsor: Daiichi Sankyo
• Collaborator: Daiichi Sankyo Co., Ltd.
• Information provided by (Responsible Party): Daiichi Sankyo

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Non-Small Cell Lung Cancer Metastatic; Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
• Interventions: Drug: Patritumab Deruxtecan (Fixed dose); Drug: Patritumab Deruxtecan (Up-Titration)
• Enrollment: 277

Participant Flow

Recruitment Details	A total of 277 participants were enrolled and randomized to treatment at clinical sites in the United States, Japan, Republic of Korea, Singapore, Taiwan, Austria, Belgium, Bulgaria, France, Germany, Italy, Netherlands, Spain, United Kingdom, and Australia. Two participants did not receive any treatment. (1 person in each treatment arm).
Pre-assignment Details

Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen
Period Title: Overall Study
Started	226	51
Completed [1]	87	14
Not Completed	139	37
Reason Not Completed
Death	114	28
Lost to Follow-up	1	1
Withdrawal by Subject	24	7
Other - Not specified	0	1
[1] Ongoing patients as of data cutoff date

Baseline Characteristics

Arm/Group Title		Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration	Total
Arm/Group Description		Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen	Total of all reporting groups
Overall Number of Baseline Participants		226	51	277
Baseline Analysis Population Description		Demographic and baseline characteristics were reported from the Full Analysis Set.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	226 participants	51 participants	277 participants
		62.7 (9.86)	59.8 (10.07)	62.2 (9.95)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	226 participants	51 participants	277 participants
<65 years		122 54.0%	36 70.6%	158 57.0%
≥65 years		104 46.0%	15 29.4%	119 43.0%
<75 years		201 88.9%	49 96.1%	250 90.3%
≥75 years		25 11.1%	2 3.9%	27 9.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	226 participants	51 participants	277 participants
	Female	133 58.8%	29 56.9%	162 58.5%
	Male	93 41.2%	22 43.1%	115 41.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	226 participants	51 participants	277 participants
Asian		106 46.9%	32 62.7%	138 49.8%
Black or African-American		3 1.3%	1 2.0%	4 1.4%
Native Hawaiian or Other Pacific Islander		1 0.4%	0 0.0%	1 0.4%
White		92 40.7%	15 29.4%	107 38.6%
Other		24 10.6%	3 5.9%	27 9.7%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Description	ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Objective response rate was assessed in the Efficacy Analysis Set.

Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed	225	50
Measure Type: Count of Participants; Unit of Measure: Participants
	64 28.4%	8 16.0%

2. Secondary Outcome

Title	Duration of Response (DoR)
Description	DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Duration of response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.

Arm/Group Title		Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:		Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed		64	8
Median (95% Confidence Interval); Unit of Measure: months
Duration of response (BICR)	Number Analyzed	64 participants	8 participants
		6.0; (4.4 to 7.2)	7.1; (2.8 to 15.2)
Duration of response (Investigator)	Number Analyzed	56 participants	8 participants
		6.9; (5.6 to 7.2)	5.1; (2.6 to 9.5)

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Progression-free survival was assessed in the Efficacy Analysis Set.

Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed	225	50
Median (95% Confidence Interval); Unit of Measure: months
Progression-free survival (BICR)	5.5; (5.1 to 5.9)	6.7; (4.2 to 8.8)
Progression-free survival (Investigator)	5.5; (4.2 to 5.7)	5.3; (4.0 to 8.2)

4. Secondary Outcome

Title	Objective Response Rate (ORR) as Assessed by the Investigator
Description	ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame	Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Objective response rate was assessed in the Efficacy Analysis Set.

Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed	225	50
Measure Type: Count of Participants; Unit of Measure: Participants
	56 24.9%	8 16.0%

5. Secondary Outcome

Title	Disease Control Rate (DCR)
Description	DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Disease control rate was assessed in the Efficacy Analysis Set.

Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed	225	50
Measure Type: Count of Participants; Unit of Measure: Participants
Disease control rate (BICR)	166 73.8%	38 76.0%
Disease control rate (Investigator)	169 75.1%	37 74.0%

6. Secondary Outcome

Title	Time to Tumor Response (TTR)
Description	TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Time to response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.

Arm/Group Title		Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:		Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed		64	8
Mean (Standard Deviation); Unit of Measure: months
Time to response (BICR)	Number Analyzed	64 participants	8 participants
		2.2 (1.31)	1.7 (0.61)
Time to response (Investigator)	Number Analyzed	56 participants	8 participants
		2.5 (1.78)	2.1 (1.09)

7. Secondary Outcome

Title	Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors
Description	The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.
Time Frame	Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Outcome Measure Data

Analysis Population Description

Percentage change in the sum of diameters was assessed in participants with available data in the Efficacy Analysis Set.

Arm/Group Title		Patritumab Deruxtecan 5.6 mg/kg	Patritumab Deruxtecan Up-Titration
Arm/Group Description:		Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Overall Number of Participants Analyzed		210	49
Mean (Standard Deviation); Unit of Measure: percentage change from baseline
Sum of diameters (BICR)	Number Analyzed	210 participants	49 participants
		-25.66 (30.39)	-17.48 (29.54)
Sum of diameters (Investigator)	Number Analyzed	208 participants	48 participants
		-20.84 (27.01)	-11.46 (29.25)

8. Secondary Outcome

Title	Overall Survival (OS)
Description	OS defined as the time from the start of study treatment to the date of death due to any cause.
Time Frame	Death date is collected until the participant discontinues the study or up to approximately 45 months

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Description	A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.
Time Frame	From baseline up to Day 47 post last dose

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date).
Adverse Event Reporting Description	Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Arm/Group Title	Patritumab Deruxtecan 5.6 mg/kg		Patritumab Deruxtecan Up-Titration
Arm/Group Description	Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)		Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
All-Cause Mortality
	Patritumab Deruxtecan 5.6 mg/kg		Patritumab Deruxtecan Up-Titration
	Affected / at Risk (%)		Affected / at Risk (%)
Total	114/225 (50.67%)		28/50 (56.00%)
Serious Adverse Events
	Patritumab Deruxtecan 5.6 mg/kg		Patritumab Deruxtecan Up-Titration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/225 (40.00%)		16/50 (32.00%)
Blood and lymphatic system disorders
Anaemia † 1	6/225 (2.67%)	6	0/50 (0.00%)	0
Febrile neutropenia † 1	5/225 (2.22%)	6	0/50 (0.00%)	0
Thrombocytopenia † 1	4/225 (1.78%)	4	0/50 (0.00%)	0
Neutropenia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Cardiac disorders
Cardiac tamponade † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Atrial fibrillation † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Cardiac disorder † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Gastrointestinal disorders
Nausea † 1	5/225 (2.22%)	5	1/50 (2.00%)	1
Vomiting † 1	3/225 (1.33%)	3	1/50 (2.00%)	1
Stomatitis † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Abdominal pain † 1	1/225 (0.44%)	1	1/50 (2.00%)	1
Colitis † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Diarrhoea † 1	1/225 (0.44%)	1	1/50 (2.00%)	1
Duodenal perforation † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Enterocolitis haemorrhagic † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Gastrointestinal haemorrhage † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Gastrointestinal perforation † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Oesophageal haemorrhage † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Pancreatic duct obstruction † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Retroperitoneal haematoma † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Constipation † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
General disorders
Disease progression † 1	11/225 (4.89%)	11	4/50 (8.00%)	4
Pyrexia † 1	3/225 (1.33%)	3	1/50 (2.00%)	1
Asthenia † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Fatigue † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Malaise † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Non-cardiac chest pain † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Chills † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
General physical health deterioration † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Mucosal inflammation † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Pain † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hepatobiliary disorders
Jaundice cholestatic † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Hepatic cytolysis † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hepatic failure † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hepatic haematoma † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hypertransaminaemia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Infections and infestations
Pneumonia † 1	5/225 (2.22%)	5	0/50 (0.00%)	0
COVID-19 † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Sepsis † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Septic shock † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Bacterial sepsis † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
COVID-19 pneumonia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Cellulitis † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Infectious pleural effusion † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Urinary tract infection † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Urosepsis † 1	1/225 (0.44%)	1	1/50 (2.00%)	1
Pyelonephritis † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
Injury, poisoning and procedural complications
Hip fracture † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Ankle fracture † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Fall † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Transfusion reaction † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Femoral neck fracture † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
Investigations
Platelet count decreased † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	4/225 (1.78%)	4	0/50 (0.00%)	0
Dehydration † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hyperglycaemia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hypokalaemia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hyponatraemia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Muscular weakness † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Osteonecrosis of jaw † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Pathological fracture † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges † 1	3/225 (1.33%)	3	0/50 (0.00%)	0
Cancer pain † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Non-small cell lung cancer † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Metastasis to central nervous system † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Nervous system disorders
Seizure † 1	4/225 (1.78%)	4	1/50 (2.00%)	1
Aphasia † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Cerebrovascular accident † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Headache † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Normal pressure hydrocephalus † 1	1/225 (0.44%)	2	0/50 (0.00%)	0
Petit mal epilepsy † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Syncope † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Transient ischaemic attack † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hypoaesthesia † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonitis † 1	9/225 (4.00%)	9	1/50 (2.00%)	1
Pleural effusion † 1	4/225 (1.78%)	6	2/50 (4.00%)	2
Respiratory failure † 1	3/225 (1.33%)	3	1/50 (2.00%)	1
Dyspnoea † 1	2/225 (0.89%)	2	0/50 (0.00%)	0
Pneumothorax † 1	2/225 (0.89%)	3	0/50 (0.00%)	0
Acute respiratory distress syndrome † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Haemothorax † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Hypercapnia † 1	1/225 (0.44%)	1	0/50 (0.00%)	0
Pulmonary embolism † 1	1/225 (0.44%)	1	1/50 (2.00%)	1
Bronchial obstruction † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
Interstitial lung disease † 1	0/225 (0.00%)	0	1/50 (2.00%)	1
1 Term from vocabulary, MedDRA25.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Patritumab Deruxtecan 5.6 mg/kg		Patritumab Deruxtecan Up-Titration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	223/225 (99.11%)		49/50 (98.00%)
Blood and lymphatic system disorders
Anaemia † 1	74/225 (32.89%)	107	15/50 (30.00%)	23
Thrombocytopenia † 1	33/225 (14.67%)	59	5/50 (10.00%)	5
Neutropenia † 1	23/225 (10.22%)	35	5/50 (10.00%)	13
Leukopenia † 1	12/225 (5.33%)	17	1/50 (2.00%)	3
Eye disorders
Vision blurred † 1	6/225 (2.67%)	6	4/50 (8.00%)	4
Gastrointestinal disorders
Nausea † 1	147/225 (65.33%)	215	32/50 (64.00%)	48
Constipation † 1	77/225 (34.22%)	95	15/50 (30.00%)	19
Diarrhoea † 1	62/225 (27.56%)	91	11/50 (22.00%)	21
Vomiting † 1	60/225 (26.67%)	70	11/50 (22.00%)	15
Stomatitis † 1	26/225 (11.56%)	30	7/50 (14.00%)	7
Abdominal pain † 1	19/225 (8.44%)	20	5/50 (10.00%)	6
Abdominal pain upper † 1	14/225 (6.22%)	15	3/50 (6.00%)	3
Dyspepsia † 1	14/225 (6.22%)	19	2/50 (4.00%)	6
Gastrooesophageal reflux disease † 1	7/225 (3.11%)	8	3/50 (6.00%)	3
General disorders
Fatigue † 1	69/225 (30.67%)	79	12/50 (24.00%)	14
Asthenia † 1	41/225 (18.22%)	70	7/50 (14.00%)	14
Pyrexia † 1	22/225 (9.78%)	30	6/50 (12.00%)	8
Oedema peripheral † 1	20/225 (8.89%)	22	3/50 (6.00%)	3
Malaise † 1	15/225 (6.67%)	23	6/50 (12.00%)	16
Infections and infestations
COVID-19 † 1	20/225 (8.89%)	23	3/50 (6.00%)	3
Pneumonia † 1	11/225 (4.89%)	12	3/50 (6.00%)	3
Urinary tract infection † 1	10/225 (4.44%)	12	3/50 (6.00%)	3
Injury, poisoning and procedural complications
Fall † 1	6/225 (2.67%)	7	4/50 (8.00%)	4
Investigations
Platelet count decreased † 1	65/225 (28.89%)	88	13/50 (26.00%)	22
Neutrophil count decreased † 1	61/225 (27.11%)	104	15/50 (30.00%)	32
White blood cell count decreased † 1	48/225 (21.33%)	85	9/50 (18.00%)	20
Aspartate aminotransferase increased † 1	38/225 (16.89%)	56	9/50 (18.00%)	13
Alanine aminotransferase increased † 1	26/225 (11.56%)	39	9/50 (18.00%)	15
Weight decreased † 1	23/225 (10.22%)	24	9/50 (18.00%)	9
Blood alkaline phosphatase increased † 1	21/225 (9.33%)	25	1/50 (2.00%)	1
Lymphocyte count decreased † 1	16/225 (7.11%)	27	3/50 (6.00%)	4
Blood lactate dehydrogenase increased † 1	13/225 (5.78%)	15	1/50 (2.00%)	1
Blood creatinine increased † 1	12/225 (5.33%)	18	3/50 (6.00%)	4
Metabolism and nutrition disorders
Decreased appetite † 1	92/225 (40.89%)	115	21/50 (42.00%)	28
Hypokalaemia † 1	37/225 (16.44%)	49	6/50 (12.00%)	8
Hypoalbuminaemia † 1	20/225 (8.89%)	27	1/50 (2.00%)	1
Hyperglycaemia † 1	15/225 (6.67%)	18	2/50 (4.00%)	3
Hyponatraemia † 1	15/225 (6.67%)	18	2/50 (4.00%)	2
Musculoskeletal and connective tissue disorders
Back pain † 1	21/225 (9.33%)	25	7/50 (14.00%)	7
Arthralgia † 1	20/225 (8.89%)	22	4/50 (8.00%)	4
Myalgia † 1	7/225 (3.11%)	7	3/50 (6.00%)	6
Nervous system disorders
Headache † 1	26/225 (11.56%)	28	9/50 (18.00%)	13
Dysgeusia † 1	14/225 (6.22%)	17	1/50 (2.00%)	1
Dizziness † 1	13/225 (5.78%)	16	4/50 (8.00%)	4
Psychiatric disorders
Insomnia † 1	17/225 (7.56%)	17	5/50 (10.00%)	5
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	40/225 (17.78%)	44	2/50 (4.00%)	2
Cough † 1	37/225 (16.44%)	40	5/50 (10.00%)	7
Epistaxis † 1	22/225 (9.78%)	27	1/50 (2.00%)	2
Skin and subcutaneous tissue disorders
Alopecia † 1	57/225 (25.33%)	57	0/50 (0.00%)	0
Pruritus † 1	13/225 (5.78%)	15	0/50 (0.00%)	0
Vascular disorders
Hypertension † 1	5/225 (2.22%)	5	3/50 (6.00%)	3
1 Term from vocabulary, MedDRA25.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

Results Point of Contact

• Name/Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo, Inc.
• Phone: 9089926400
• EMail: CTRinfo@dsi.com

• Responsible Party: Daiichi Sankyo
• ClinicalTrials.gov Identifier: NCT04619004
• Other Study ID Numbers: U31402-A-U201; 2020-000730-17 ( EudraCT Number )
• First Submitted: October 29, 2020
• First Posted: November 6, 2020
• Results First Submitted: March 4, 2024
• Results First Posted: April 2, 2024
• Last Update Posted: April 2, 2024