Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bemarituzumab · 3 trials · 3 indications
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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.
| Arm | Type | Description |
|---|---|---|
| Bemarituzumab with mFOLFOX6 | EXPERIMENTAL | - |
| Placebo with mFOLFOX6 | ACTIVE_COMPARATOR | - |
| Bemarituzumab + mFOLFOX6 | EXPERIMENTAL | 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 mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death. |
| Placebo + mFOLFOX6 | PLACEBO_COMPARATOR | Participants received placebo for bemarituzumab administered every 2 weeks 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. |
| Part 1 Cohort A: Bemarituzumab with CAPOX | EXPERIMENTAL | - |
| Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab | EXPERIMENTAL | - |
| Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab | EXPERIMENTAL | - |
| Part 2: Bemarituzumab with SOX and Nivolumab. | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bemarituzumab | DRUG | Intravenous (IV) infusion |
| mFOLFOX6 | DRUG | mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion. |
| Placebo | DRUG | IV infusion |
| Modified FOLFOX6 | DRUG | 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 |
| CAPOX | DRUG | CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets. |
| SOX | DRUG | SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally. |
| Nivolumab | DRUG | IV infusion. |
Inclusion Criteria: * Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy * Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed i...
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