Gastric Cancer
Conditions
Brief summary
The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.
Detailed description
Study FPA144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of bemarituzumab in combination with mFOLFOX6, compared with placebo in combination with mFOLFOX6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (GEJ). This study includes a Phase 1 safety run-in portion and a Phase 2 portion. The Phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mFOLFOX6 in patients with GI tumors (not FGFR2 selected) that is reported separately (NCT03343301). The Phase 2 portion of the study (to follow the Phase 1 safety run-in) is described in this record.
Interventions
BIOLOGICALBemarituzumab
Administered by intravenous infusion over approximately 30 minutes
DRUGPlacebo
Administered by intravenous infusion over approximately 30 minutes
DRUGModified FOLFOX6
mFOLFOX6 regimen consists of the following: * Oxaliplatin 85 mg/m² IV infusion over 120 minutes * Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable * 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Five Prime Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded (participant, treating physician)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1 * Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay * Candidate for mFOLFOX6 chemotherapy Key
Exclusion criteria
* Untreated or symptomatic central nervous system (CNS) metastases * Clinically significant cardiac disease, * Peripheral sensory neuropathy \>/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 * Active infection requiring systemic treatment * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection * Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway * Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer * Known positivity for human epidermal growth factor receptor 2 (HER2) * Women who are pregnant or breastfeeding Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months. | 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. |
| Overall Response Rate (ORR) | 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. | 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. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | 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). |
Countries
Australia, Belgium, China, France, Germany, Hungary, Italy, Japan, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Bemarituzumab + mFOLFOX6 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. | 77 |
| Placebo + mFOLFOX6 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. | 78 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Physician Decision | 53 | 54 |
| Overall Study | Withdrawal by Subject | 8 | 10 |
Baseline characteristics
| Characteristic | Total | Placebo + mFOLFOX6 | Bemarituzumab + mFOLFOX6 |
|---|---|---|---|
| Administration of a Single Dose of mFOLFOX6 Prior to Enrollment No | 84 Participants | 42 Participants | 42 Participants |
| Administration of a Single Dose of mFOLFOX6 Prior to Enrollment Yes | 71 Participants | 36 Participants | 35 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 25 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 53 Participants | 58 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 11.56 | 59.1 years STANDARD_DEVIATION 12.04 | 58.0 years STANDARD_DEVIATION 11.11 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active) | 53 Participants | 28 Participants | 25 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restricted activity but ambulatory) | 102 Participants | 50 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 75 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Geographic Region China | 27 Participants | 13 Participants | 14 Participants |
| Geographic Region Rest of Asia | 62 Participants | 31 Participants | 31 Participants |
| Geographic Region United States / European Union | 66 Participants | 34 Participants | 32 Participants |
| Prior Treatment Status No prior adjuvant/neo-adjuvant therapy | 128 Participants | 65 Participants | 63 Participants |
| Prior Treatment Status Prior adjuvant/neo-adjuvant therapy | 27 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 89 Participants | 44 Participants | 45 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 31 Participants | 30 Participants |
| Sex: Female, Male Female | 44 Participants | 19 Participants | 25 Participants |
| Sex: Female, Male Male | 111 Participants | 59 Participants | 52 Participants |
| Site of Primary Cancer Gastric cancer | 137 Participants | 71 Participants | 66 Participants |
| Site of Primary Cancer Gastroesophageal junction cancer | 18 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 53 / 77 | 55 / 78 |
| other Total, other adverse events | 75 / 76 | 75 / 77 |
| serious Total, serious adverse events | 26 / 76 | 28 / 77 |
Outcome results
Primary
Progression-Free Survival (PFS)
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.
Population: Intent-to-treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bemarituzumab + mFOLFOX6 | Progression-Free Survival (PFS) | 9.5 months |
| Placebo + mFOLFOX6 | Progression-Free Survival (PFS) | 7.4 months |
p-value: 0.072795% CI: [0.44, 1.04]Stratified log-rank test
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Population: Safety population includes all participants who received any portion of at least 1 dose of study treatment (bemarituzumab + mFOLFOX6 or placebo + mFOLFOX6).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 76 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with Grade ≥ 3 | 63 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE related to any study drug | 72 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with Grade ≥ 3 related to any study drug | 57 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse event (SAE) | 26 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | SAE related to any study drug | 11 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of bemarituzumab/placebo | 31 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of any component of mFOLFOX6 | 35 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose reduction of bemarituzumab/placebo | 9 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose reduction of any agent of mFOLFOX6 | 48 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose delay of bemarituzumab/placebo | 51 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose delay of any agent of mFOLFOX6 | 54 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to Infusion interruption of bemarituzumab/placebo | 3 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to infusion interruption of any agent of mFOLFOX6 | 10 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE | 51 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE with Grade ≥ 3 | 21 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE related to bemarituzumab/placebo | 46 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo | 24 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE | 18 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE with Grade ≥ 3 | 1 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE related to bemarituzumab/placebo | 12 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo | 2 Participants |
| Bemarituzumab + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to death (Grade 5) | 5 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose delay of any agent of mFOLFOX6 | 44 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 76 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo | 0 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with Grade ≥ 3 | 58 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to Infusion interruption of bemarituzumab/placebo | 3 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE related to any study drug | 73 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE related to bemarituzumab/placebo | 5 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with Grade ≥ 3 related to any study drug | 48 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to infusion interruption of any agent of mFOLFOX6 | 17 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious adverse event (SAE) | 28 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE | 7 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | SAE related to any study drug | 15 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE | 8 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of bemarituzumab/placebo | 4 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to death (Grade 5) | 4 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation of any component of mFOLFOX6 | 29 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE with Grade ≥ 3 | 0 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose reduction of bemarituzumab/placebo | 7 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorders (SMQ) TEAE with Grade ≥ 3 | 0 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose reduction of any agent of mFOLFOX6 | 44 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Corneal disorders (SMQ) TEAE related to bemarituzumab/placebo | 7 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to dose delay of bemarituzumab/placebo | 41 Participants |
| Placebo + mFOLFOX6 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Retinal disorder (SMQ) TEAE leading to discontinuation of bemarituzumab/placebo | 0 Participants |
Secondary
Overall Response Rate (ORR)
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.
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bemarituzumab + mFOLFOX6 | Overall Response Rate (ORR) | 46.8 percentage of participants |
| Placebo + mFOLFOX6 | Overall Response Rate (ORR) | 33.3 percentage of participants |
p-value: 0.10695% CI: [-2.8, 29]Cochran-Mantel-Haenszel
Secondary
Overall Survival (OS)
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.
Population: Intent-to-treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bemarituzumab + mFOLFOX6 | Overall Survival (OS) | NA months |
| Placebo + mFOLFOX6 | Overall Survival (OS) | 12.9 months |
p-value: 0.026895% CI: [0.35, 0.95]Stratified log-rank test
Post Hoc
Overall Survival - Updated Analysis
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.
Population: Intent-to-treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bemarituzumab + mFOLFOX6 | Overall Survival - Updated Analysis | 19.2 months |
| Placebo + mFOLFOX6 | Overall Survival - Updated Analysis | 13.5 months |
95% CI: [0.38, 0.94]