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Also known as FPA144, AMG 552
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.
DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE * Grade 4: Life-threatening consequences; urgent intervention indicated
| 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. |
| FPA144 | EXPERIMENTAL | Participants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria. |
| 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 |
| FPA144 | DRUG | FPA144 will be administered intravenously Q2W. |
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 studied for gastric cancer and gastroesophageal junction adenocarcinoma. It is specifically evaluated in tumors with FGFR2b overexpression, a biomarker-selected population. It is not approved and remains in clinical development.
Bemarituzumab targets FGFR2 and FCGR3A. It is an inhibitor designed to block fibroblast growth factor receptor 2b (FGFR2b) signaling, which can drive tumor growth in cancers with FGFR2b overexpression. The FCGR3A interaction supports immune-mediated mechanisms.
Bemarituzumab is being developed by Amgen Inc., which trades under the ticker AMGN. Amgen is responsible for the clinical program evaluating the drug in gastric and gastroesophageal junction cancers.
Bemarituzumab is in Phase 3 clinical development. It has not been approved by the FDA or any regulatory agency. The Phase 3 program is designed to confirm safety and efficacy in biomarker-selected patients with FGFR2b-overexpressing gastric cancer.
Bemarituzumab has been studied in two completed trials: NCT05052801, a Phase 3 trial of bemarituzumab or placebo plus chemotherapy in FGFR2b-overexpressing gastric cancers, and NCT03694522, a Phase 2 trial of bemarituzumab combined with modified FOLFOX6 in gastric/gastroesophageal junction cancer.
Yes, FPA144 is an alternative name for bemarituzumab. Both names refer to the same investigational monoclonal antibody developed by Amgen. The drug is also known by its ChEMBL identifier CHEMBL4802165.