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Bemarituzumab · 2 trials · 2 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. |
| 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 |
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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Bemarituzumab is an investigational monoclonal antibody being developed for the treatment of gastric cancer, including gastroesophageal junction adenocarcinoma. It is studied in combination with chemotherapy in patients whose tumors overexpress fibroblast growth factor receptor 2b (FGFR2b). The drug is currently in Phase 3 clinical development and is not yet approved.
Bemarituzumab targets fibroblast growth factor receptor 2b (FGFR2b), a protein overexpressed in certain gastric cancers. By binding to FGFR2b, the antibody is designed to interfere with signaling pathways that promote tumor growth. This biomarker-selected approach aims to treat patients whose tumors have FGFR2b overexpression.
Bemarituzumab is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in gastric cancer.
Bemarituzumab is in Phase 3 clinical development for gastric cancer. A Phase 3 trial (NCT05052801) comparing bemarituzumab or placebo plus chemotherapy in gastric cancers with FGFR2b overexpression has been completed. The drug remains investigational and has not received FDA approval.
Bemarituzumab has been studied in two completed trials. NCT03694522 was a Phase 2 study of bemarituzumab combined with modified FOLFOX6 in gastric/gastroesophageal junction cancer, enrolling 155 participants. NCT05052801 was a Phase 3 trial of bemarituzumab or placebo plus chemotherapy in gastric cancers with FGFR2b overexpression, enrolling 547 participants.
Bemarituzumab is also known as FPA144. The Phase 2 trial NCT03694522 was titled 'A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer,' confirming that FPA144 is an alternative name for the same drug.