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Also known as Bemarituzumab, AMG 552
FPA144 · 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...
FPA144 is an investigational monoclonal antibody being studied for the treatment of advanced gastric or gastroesophageal cancer. It is in Phase 1 clinical development and has been evaluated in Japanese patients with these tumor types. FPA144 is not yet approved for any indication.
FPA144 is being developed by Amgen Inc., a biotechnology company whose common stock trades on Nasdaq under the ticker symbol AMGN. Amgen is the sponsor of the clinical program evaluating FPA144 in advanced gastric or gastroesophageal cancer.
FPA144 is in Phase 1 clinical development. The single completed trial was a Phase 1 study, and no active trials are currently listed. As a Phase 1 asset, FPA144 remains investigational and has not been approved by the FDA or any other regulatory agency.
FPA144 has been evaluated in one completed clinical trial, NCT05913115, titled A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer. The Phase 1 study enrolled 6 participants in Japan and was uncontrolled, non-randomized, and not blinded.
No, FPA144 is not FDA approved. It is an investigational monoclonal antibody in Phase 1 development for advanced gastric or gastroesophageal cancer. The only completed trial, NCT05913115, was a small Phase 1 study, and no regulatory approvals have been granted for FPA144.