A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

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ClinicalTrials.gov Identifier: NCT03694522

Recruitment Status : Completed

First Posted : October 3, 2018

Results First Posted : May 24, 2022

Last Update Posted : February 28, 2024

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Sponsor:

Collaborator:

Zai Lab (Shanghai) Co., Ltd.

Information provided by (Responsible Party):

Five Prime Therapeutics, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Gastric Cancer
Interventions	Biological: Bemarituzumab Drug: Placebo Drug: Modified FOLFOX6
Enrollment	155

Participant Flow

Recruitment Details

Study FPA144-004 was a Phase 1/2 study. Phase 1 was a safety run-in to determine the recommended dose of bemarituzumab to be administered in combination with a fixed dose of modified FOLFOX 6 (mFOLFOX6) chemotherapy regimen in the phase 2 part of the study. Phase 1 study details and results are reported separately (NCT03343301); Phase 2 study results are reported below.

Pre-assignment Details

Participants were randomized equally to one of two treatment groups stratified based on the following factors:

Geographic region: United States/European Union, China, or Rest of Asia
Prior treatment status: de novo (no prior adjuvant/neo-adjuvant therapy) or prior adjuvant/neo-adjuvant therapy
Administration of a single dose of mFOLFOX6 prior to enrollment: Yes or No.


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description	Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received modified FOLFOX (mFOLFOX6) chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Period Title: Overall Study
Started	77	78
Received Any Study Treatment	76	77
Completed	15	12
Not Completed	62	66
Reason Not Completed
Withdrawal by Subject	8	10
Physician Decision	53	54
Other	1	1
Lost to Follow-up	0	1

Baseline Characteristics

Arm/Group Title		Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6	Total
Arm/Group Description		Participants received 15 mg/kg bema...	Participants received placebo for b...	Total of all reporting groups
Arm/Group Description		Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Total of all reporting groups
Overall Number of Baseline Participants		77	78	155
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The intent-to-treat (ITT) population includes all participants who were randomized in the study.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	58 75.3%	53 67.9%	111 71.6%
	>=65 years	19 24.7%	25 32.1%	44 28.4%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	77 participants	78 participants	155 participants
		58.0 (11.11)	59.1 (12.04)	58.5 (11.56)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Female	25 32.5%	19 24.4%	44 28.4%
	Male	52 67.5%	59 75.6%	111 71.6%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Hispanic or Latino	2 2.6%	3 3.8%	5 3.2%
	Not Hispanic or Latino	74 96.1%	75 96.2%	149 96.1%
	Unknown or Not Reported	1 1.3%	0 0.0%	1 0.6%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Asian	45 58.4%	44 56.4%	89 57.4%
	Black or African American	0 0.0%	1 1.3%	1 0.6%
	American Indian or Alaska Native	0 0.0%	1 1.3%	1 0.6%
	White	30 39.0%	31 39.7%	61 39.4%
	Other	2 2.6%	1 1.3%	3 1.9%
Geographic Region ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	United States / European Union	32 41.6%	34 43.6%	66 42.6%
	China	14 18.2%	13 16.7%	27 17.4%
	Rest of Asia	31 40.3%	31 39.7%	62 40.0%
		[1] Measure Description: European Union (EU) includes Italy, Turkey, Spain, Portugal, Hungary, Germany, France, Romania, Poland, and the United Kingdom. Rest of Asia includes Japan, Taiwan, and South Korea.
Prior Treatment Status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Prior adjuvant/neo-adjuvant therapy	14 18.2%	13 16.7%	27 17.4%
	No prior adjuvant/neo-adjuvant therapy	63 81.8%	65 83.3%	128 82.6%
Administration of a Single Dose of mFOLFOX6 Prior to Enrollment Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Yes	35 45.5%	36 46.2%	71 45.8%
	No	42 54.5%	42 53.8%	84 54.2%
Site of Primary Cancer Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Gastric cancer	66 85.7%	71 91.0%	137 88.4%
	Gastroesophageal junction cancer	11 14.3%	7 9.0%	18 11.6%
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	0 (Fully active)	25 32.5%	28 35.9%	53 34.2%
	1 (Restricted activity but ambulatory)	52 67.5%	50 64.1%	102 65.8%
		[1] Measure Description: A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was defined as time from randomization until the date of radiograp...
Description	PFS was defined as time from randomization until the date of radiographic disease progression based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death from any cause, whichever came first. PFS was analyzed using Kaplan-Meier methods. Participants with no progression or death, or who started new anticancer therapy before documented progression or death without documented progression, or who had ≥ 2 consecutive missing tumor assessments before documented progression or death without documented progression were censored on the date of last adequate tumor assessment. Participants with no baseline tumor assessment, were censored at the date of randomization. The primary efficacy analysis was pre-specified to be conducted after at least 84 PFS events were observed.
Time Frame	From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.

Outcome Measure Data

Analysis Population Description

Intent-to-treat population


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description:	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description:	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Number of Participants Analyzed	77	78
Median (95% Confidence Interval) Unit of Measure: months
	9.5 (7.3 to 12.9)	7.4 (5.8 to 8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bemarituzumab + mFOLFOX6, Placebo + mFOLFOX6
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0727
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.44 to 1.04
	Estimation Comments	Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.

2.Secondary Outcome


Title	Overall Survival (OS)
Description	OS is defined as time from randomization until death from any cause. P...
Description	OS is defined as time from randomization until death from any cause. Participants who were lost to follow-up or did not have a date of death were censored at the last date that they were known to be alive. Participants with confirmed death or alive status after the data cutoff date were censored at the data cutoff date. Median OS was estimated using a Kaplan-Meier analysis.
Time Frame	From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.

Outcome Measure Data

Analysis Population Description

Intent-to-treat population


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description:	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description:	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Number of Participants Analyzed	77	78
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (13.8 to NA)	12.9 (9.1 to 15.0)

[1]

Could not be estimated due to the low number of events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bemarituzumab + mFOLFOX6, Placebo + mFOLFOX6
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0268
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95% 0.35 to 0.95
	Estimation Comments	Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.

3.Secondary Outcome


Title	Overall Response Rate (ORR)
Description	Tumor response assessment was performed by the investigator per Respon...
Description	Tumor response assessment was performed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. ORR is defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. CR was defined as the disappearance of all lesions except lymph node short axis < 10 mm; PR was defined as a ≥ 30% reduction in sum of diameters in target lesions.
Time Frame	Tumor assessments were performed every 8 weeks until 12 months and then every 12 weeks thereafter until disease progression or additional anticancer therapy was initiated; the median duration of follow-up time was 10.9 months.

Outcome Measure Data

Analysis Population Description

Intent-to-treat population


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description:	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description:	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Number of Participants Analyzed	77	78
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	46.8 (35.3 to 58.5)	33.3 (23.1 to 44.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bemarituzumab + mFOLFOX6, Placebo + mFOLFOX6
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1060
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	13.1
	Confidence Interval	(2-Sided) 95% -2.8 to 29.0
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	TEAEs are defined as adverse events (AEs) that started or worsened fro...
Description	TEAEs are defined as adverse events (AEs) that started or worsened from the start of study drug to 28 days after permanent discontinuation of study drug. A serious AE is defined as any untoward medical occurrence that: Resulted in death; Was life-threatening; Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect. The investigator assessed the causality/relationship between study treatment and each AE, and assessed the severity of each AE according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Cornea and retina AEs were defined by Standardized Medical Dictionary for Regulatory Activities Queries (SMQs) of corneal disorders and retinal disorders (broad).
Time Frame	From first dose of study drug to 28 days after last dose of study drug. Actual median (min, max) duration of treatment emergent period was 29 (4.1, 157) weeks in the bemarituzumab + mFOLFOX6 group and 28 (4.3, 133) weeks in the placebo + mFOLFOX6 group.

Outcome Measure Data

Analysis Population Description

Safety population includes all participants who received any portion of at least 1 dose of study treatment (bemarituzumab + mFOLFOX6 or placebo + mFOLFOX6).


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description:	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description:	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Number of Participants Analyzed	76	77
Measure Type: Count of Participants Unit of Measure: Participants
Any treatment-emergent adverse event (TEAE)	76 100.0%	76 98.7%
TEAE with Grade ≥ 3	63 82.9%	58 75.3%
TEAE related to any study drug	72 94.7%	73 94.8%
TEAE with Grade ≥ 3 related to any study drug	57 75.0%	48 62.3%
Serious adverse event (SAE)	26 34.2%	28 36.4%
SAE related to any study drug	11 14.5%	15 19.5%
TEAE leading to discontinuation of bemarituzumab/placebo	31 40.8%	4 5.2%
TEAE leading to discontinuation of any component of mFOLFOX6	35 46.1%	29 37.7%
TEAE leading to dose reduction of bemarituzumab/placebo	9 11.8%	7 9.1%
TEAE leading to dose reduction of any agent of mFOLFOX6	48 63.2%	44 57.1%
TEAE leading to dose delay of bemarituzumab/placebo	51 67.1%	41 53.2%
TEAE leading to dose delay of any agent of mFOLFOX6	54 71.1%	44 57.1%
TEAE leading to Infusion interruption of bemarituzumab/placebo	3 3.9%	3 3.9%
TEAE leading to infusion interruption of any agent of mFOLFOX6	10 13.2%	17 22.1%
Corneal disorders (SMQ) TEAE	51 67.1%	8 10.4%
Corneal disorders (SMQ) TEAE with Grade ≥ 3	21 27.6%	0 0.0%
Corneal disorders (SMQ) TEAE related to bemarituzumab/placebo	46 60.5%	7 9.1%
Corneal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo	24 31.6%	0 0.0%
Retinal disorders (SMQ) TEAE	18 23.7%	7 9.1%
Retinal disorders (SMQ) TEAE with Grade ≥ 3	1 1.3%	0 0.0%
Retinal disorders (SMQ) TEAE related to bemarituzumab/placebo	12 15.8%	5 6.5%
Retinal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo	2 2.6%	0 0.0%
TEAE leading to death (Grade 5)	5 6.6%	4 5.2%

5.Post-Hoc Outcome


Title	Overall Survival - Updated Analysis
Description	OS is defined as time from randomization until death from any cause. P...
Description	OS is defined as time from randomization until death from any cause. Participants who were lost to follow-up or did not have a date of death were censored at the last date that they were known to be alive. Median OS was estimated using a Kaplan-Meier analysis.
Time Frame	From randomization until 28 February 2021; median time on follow-up was 12.5 months.

Outcome Measure Data

Analysis Population Description

Intent-to-treat population


Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description:	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description:	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Number of Participants Analyzed	77	78
Median (95% Confidence Interval) Unit of Measure: months
	19.2 ^[1] (13.6 to NA)	13.5 (9.3 to 15.9)

[1]

Could not be estimated due to the low number of events at the time of the data cut.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bemarituzumab + mFOLFOX6, Placebo + mFOLFOX6
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95% 0.38 to 0.94
	Estimation Comments	Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.

Adverse Events

Time Frame	All-cause mortality: From randomization until the end of study; median (min, max) time on study was 69.6 (0.1, 176.1) weeks in the Bemarituzumab + mFOLFOX6 group and 47.7 (0.6, 172.9) weeks in the Placebo + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; actual median (min, max) duration of treatment emergent period was 29.4 (4.1, 157.0) weeks in the Bemarituzumab + mFOLFOX6 group and 28.3 (4.3, 133.0) weeks in the Placebo + mFOLFOX6 group.
Adverse Event Reporting Description	All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Arm/Group Title	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
Arm/Group Description	Participants received 15 mg/kg bema...	Participants received placebo for b...
Arm/Group Description	Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Participants received placebo for bemarituzumab administered Q2W with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
All-Cause Mortality
	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
	Affected / at Risk (%)	Affected / at Risk (%)
Total	53/77 (68.83%)	55/78 (70.51%)
Serious Adverse Events Serious Adverse Events
	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
	Affected / at Risk (%)	Affected / at Risk (%)
Total	26/76 (34.21%)	28/77 (36.36%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/76 (2.63%)	1/77 (1.30%)
Febrile neutropenia ^† 1	0/76 (0.00%)	2/77 (2.60%)
Leukopenia ^† 1	1/76 (1.32%)	0/77 (0.00%)
Neutropenia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Thrombotic microangiopathy ^† 1	1/76 (1.32%)	0/77 (0.00%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/76 (0.00%)	1/77 (1.30%)
Coronary artery disease ^† 1	1/76 (1.32%)	0/77 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/76 (1.32%)	1/77 (1.30%)
Ascites ^† 1	0/76 (0.00%)	1/77 (1.30%)
Constipation ^† 1	0/76 (0.00%)	2/77 (2.60%)
Diarrhoea ^† 1	0/76 (0.00%)	1/77 (1.30%)
Dysphagia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Enterocolitis ^† 1	0/76 (0.00%)	1/77 (1.30%)
Gastric perforation ^† 1	0/76 (0.00%)	1/77 (1.30%)
Gastrointestinal haemorrhage ^† 1	0/76 (0.00%)	1/77 (1.30%)
Ileus ^† 1	2/76 (2.63%)	2/77 (2.60%)
Intestinal obstruction ^† 1	0/76 (0.00%)	1/77 (1.30%)
Mechanical ileus ^† 1	1/76 (1.32%)	0/77 (0.00%)
Nausea ^† 1	0/76 (0.00%)	1/77 (1.30%)
Oesophageal perforation ^† 1	1/76 (1.32%)	0/77 (0.00%)
Stomatitis ^† 1	1/76 (1.32%)	0/77 (0.00%)
Upper gastrointestinal haemorrhage ^† 1	0/76 (0.00%)	1/77 (1.30%)
Vomiting ^† 1	2/76 (2.63%)	2/77 (2.60%)
General disorders
Asthenia ^† 1	0/76 (0.00%)	2/77 (2.60%)
Death ^† 1	0/76 (0.00%)	1/77 (1.30%)
Incarcerated hernia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Pyrexia ^† 1	1/76 (1.32%)	3/77 (3.90%)
Hepatobiliary disorders
Cholangitis ^† 1	1/76 (1.32%)	0/77 (0.00%)
Cholecystitis ^† 1	0/76 (0.00%)	1/77 (1.30%)
Jaundice cholestatic ^† 1	1/76 (1.32%)	0/77 (0.00%)
Immune system disorders
Anaphylactic reaction ^† 1	1/76 (1.32%)	1/77 (1.30%)
Drug hypersensitivity ^† 1	0/76 (0.00%)	1/77 (1.30%)
Hypersensitivity ^† 1	2/76 (2.63%)	0/77 (0.00%)
Infections and infestations
Appendicitis perforated ^† 1	1/76 (1.32%)	0/77 (0.00%)
Biliary tract infection ^† 1	1/76 (1.32%)	0/77 (0.00%)
Lung abscess ^† 1	1/76 (1.32%)	0/77 (0.00%)
Pneumonia ^† 1	2/76 (2.63%)	3/77 (3.90%)
Pneumonia aspiration ^† 1	0/76 (0.00%)	1/77 (1.30%)
Pneumonia bacterial ^† 1	0/76 (0.00%)	1/77 (1.30%)
Sepsis ^† 1	2/76 (2.63%)	1/77 (1.30%)
Urinary tract infection ^† 1	1/76 (1.32%)	0/77 (0.00%)
Injury, poisoning and procedural complications
Femoral neck fracture ^† 1	0/76 (0.00%)	1/77 (1.30%)
Infusion related reaction ^† 1	1/76 (1.32%)	1/77 (1.30%)
Procedural complication ^† 1	1/76 (1.32%)	0/77 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	0/76 (0.00%)	1/77 (1.30%)
Aspartate aminotransferase increased ^† 1	0/76 (0.00%)	1/77 (1.30%)
Neutrophil count decreased ^† 1	1/76 (1.32%)	2/77 (2.60%)
Transaminases increased ^† 1	0/76 (0.00%)	1/77 (1.30%)
White blood cell count decreased ^† 1	0/76 (0.00%)	2/77 (2.60%)
White blood cell count increased ^† 1	1/76 (1.32%)	0/77 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/76 (1.32%)	1/77 (1.30%)
Failure to thrive ^† 1	0/76 (0.00%)	1/77 (1.30%)
Hypokalaemia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Hypomagnesaemia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Hypophagia ^† 1	0/76 (0.00%)	1/77 (1.30%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/76 (0.00%)	1/77 (1.30%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion ^† 1	0/76 (0.00%)	1/77 (1.30%)
Tumour haemorrhage ^† 1	0/76 (0.00%)	2/77 (2.60%)
Nervous system disorders
Headache ^† 1	1/76 (1.32%)	0/77 (0.00%)
Ischaemic stroke ^† 1	1/76 (1.32%)	0/77 (0.00%)
Product Issues
Device issue ^† 1	0/76 (0.00%)	1/77 (1.30%)
Psychiatric disorders
Completed suicide ^† 1	0/76 (0.00%)	1/77 (1.30%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/76 (1.32%)	1/77 (1.30%)
Hydronephrosis ^† 1	0/76 (0.00%)	1/77 (1.30%)
Urinary tract obstruction ^† 1	1/76 (1.32%)	0/77 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/76 (1.32%)	0/77 (0.00%)
Pulmonary embolism ^† 1	1/76 (1.32%)	0/77 (0.00%)
Vascular disorders
Embolism ^† 1	1/76 (1.32%)	0/77 (0.00%)
Hypovolaemic shock ^† 1	0/76 (0.00%)	1/77 (1.30%)
1 Term from vocabulary, MedDRA 25.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bemarituzumab + mFOLFOX6	Placebo + mFOLFOX6
	Affected / at Risk (%)	Affected / at Risk (%)
Total	75/76 (98.68%)	75/77 (97.40%)
Blood and lymphatic system disorders
Anaemia ^† 1	25/76 (32.89%)	28/77 (36.36%)
Leukopenia ^† 1	8/76 (10.53%)	9/77 (11.69%)
Neutropenia ^† 1	15/76 (19.74%)	13/77 (16.88%)
Thrombocytopenia ^† 1	11/76 (14.47%)	4/77 (5.19%)
Eye disorders
Cataract ^† 1	7/76 (9.21%)	1/77 (1.30%)
Corneal disorder ^† 1	4/76 (5.26%)	0/77 (0.00%)
Corneal epithelium defect ^† 1	7/76 (9.21%)	0/77 (0.00%)
Dry eye ^† 1	21/76 (27.63%)	5/77 (6.49%)
Keratitis ^† 1	11/76 (14.47%)	1/77 (1.30%)
Limbal stem cell deficiency ^† 1	6/76 (7.89%)	0/77 (0.00%)
Punctate keratitis ^† 1	10/76 (13.16%)	2/77 (2.60%)
Ulcerative keratitis ^† 1	4/76 (5.26%)	0/77 (0.00%)
Vision blurred ^† 1	13/76 (17.11%)	1/77 (1.30%)
Gastrointestinal disorders
Abdominal distension ^† 1	4/76 (5.26%)	6/77 (7.79%)
Abdominal pain ^† 1	17/76 (22.37%)	20/77 (25.97%)
Abdominal pain upper ^† 1	6/76 (7.89%)	5/77 (6.49%)
Constipation ^† 1	23/76 (30.26%)	24/77 (31.17%)
Diarrhoea ^† 1	31/76 (40.79%)	23/77 (29.87%)
Dyspepsia ^† 1	7/76 (9.21%)	9/77 (11.69%)
Dysphagia ^† 1	1/76 (1.32%)	4/77 (5.19%)
Nausea ^† 1	37/76 (48.68%)	41/77 (53.25%)
Stomatitis ^† 1	26/76 (34.21%)	10/77 (12.99%)
Vomiting ^† 1	23/76 (30.26%)	23/77 (29.87%)
General disorders
Asthenia ^† 1	20/76 (26.32%)	16/77 (20.78%)
Fatigue ^† 1	16/76 (21.05%)	21/77 (27.27%)
Mucosal inflammation ^† 1	8/76 (10.53%)	4/77 (5.19%)
Oedema peripheral ^† 1	4/76 (5.26%)	4/77 (5.19%)
Pyrexia ^† 1	10/76 (13.16%)	12/77 (15.58%)
Infections and infestations
Conjunctivitis ^† 1	5/76 (6.58%)	2/77 (2.60%)
Onychomycosis ^† 1	4/76 (5.26%)	0/77 (0.00%)
Injury, poisoning and procedural complications
Infusion related reaction ^† 1	6/76 (7.89%)	7/77 (9.09%)
Investigations
Alanine aminotransferase increased ^† 1	23/76 (30.26%)	11/77 (14.29%)
Aspartate aminotransferase increased ^† 1	24/76 (31.58%)	15/77 (19.48%)
Blood alkaline phosphatase increased ^† 1	7/76 (9.21%)	5/77 (6.49%)
Blood bilirubin increased ^† 1	7/76 (9.21%)	4/77 (5.19%)
Blood creatinine increased ^† 1	2/76 (2.63%)	4/77 (5.19%)
Neutrophil count decreased ^† 1	31/76 (40.79%)	33/77 (42.86%)
Platelet count decreased ^† 1	14/76 (18.42%)	21/77 (27.27%)
Weight decreased ^† 1	16/76 (21.05%)	10/77 (12.99%)
Weight increased ^† 1	0/76 (0.00%)	4/77 (5.19%)
White blood cell count decreased ^† 1	16/76 (21.05%)	12/77 (15.58%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	23/76 (30.26%)	28/77 (36.36%)
Hypoalbuminaemia ^† 1	4/76 (5.26%)	10/77 (12.99%)
Hypokalaemia ^† 1	4/76 (5.26%)	7/77 (9.09%)
Hypomagnesaemia ^† 1	4/76 (5.26%)	1/77 (1.30%)
Hyponatraemia ^† 1	5/76 (6.58%)	4/77 (5.19%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	3/76 (3.95%)	5/77 (6.49%)
Myalgia ^† 1	4/76 (5.26%)	4/77 (5.19%)
Pain in extremity ^† 1	1/76 (1.32%)	5/77 (6.49%)
Nervous system disorders
Dizziness ^† 1	6/76 (7.89%)	4/77 (5.19%)
Dysgeusia ^† 1	5/76 (6.58%)	6/77 (7.79%)
Headache ^† 1	7/76 (9.21%)	4/77 (5.19%)
Neuropathy peripheral ^† 1	13/76 (17.11%)	11/77 (14.29%)
Neurotoxicity ^† 1	3/76 (3.95%)	5/77 (6.49%)
Paraesthesia ^† 1	13/76 (17.11%)	10/77 (12.99%)
Peripheral sensory neuropathy ^† 1	15/76 (19.74%)	15/77 (19.48%)
Psychiatric disorders
Insomnia ^† 1	2/76 (2.63%)	5/77 (6.49%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	8/76 (10.53%)	8/77 (10.39%)
Epistaxis ^† 1	17/76 (22.37%)	3/77 (3.90%)
Rhinorrhoea ^† 1	3/76 (3.95%)	5/77 (6.49%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	5/76 (6.58%)	6/77 (7.79%)
Nail disorder ^† 1	6/76 (7.89%)	1/77 (1.30%)
Onycholysis ^† 1	5/76 (6.58%)	1/77 (1.30%)
Onychomadesis ^† 1	5/76 (6.58%)	1/77 (1.30%)
Palmar-plantar erythrodysaesthesia syndrome ^† 1	6/76 (7.89%)	1/77 (1.30%)
Pruritus ^† 1	8/76 (10.53%)	8/77 (10.39%)
Rash ^† 1	4/76 (5.26%)	2/77 (2.60%)
Urticaria ^† 1	4/76 (5.26%)	3/77 (3.90%)
Vascular disorders
Hypertension ^† 1	2/76 (2.63%)	5/77 (6.49%)
1 Term from vocabulary, MedDRA 25.0 † 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 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 CTA generally does not restrict an investigator's discussion of trial results after completion. Amgen has limited time to review material discussing trial results (up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control/approval of content. For multicenter studies, PI agrees not to publish results before first multi-center publication for at least 18 mo after study completion at all sites & all analyses of data resulting from Study.

Results Point of Contact

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Name/Title:	Study Director
Organization:	Amgen
Phone:	866-572-6436
EMail:	medinfo@amgen.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wainberg ZA, Enzinger PC, Kang YK, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Borg C, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Collins H, Mitra S, Yang Y, Catenacci DVT, Lee KW. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022 Nov;23(11):1430-1440. doi: 10.1016/S1470-2045(22)00603-9. Epub 2022 Oct 14.

Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

Layout table for additonal information

Responsible Party:	Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT03694522
Other Study ID Numbers:	FPA144-004 Phase 2 2017-003507-22 ( EudraCT Number ) 20210113 ( Other Identifier: Amgen )
First Submitted:	September 14, 2018
First Posted:	October 3, 2018
Results First Submitted:	April 28, 2022
Results First Posted:	May 24, 2022
Last Update Posted:	February 28, 2024

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