Therapy Detail
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| Therapy Name | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Bemarituzumab | FPA144 | FGFR2 Antibody 3 | Bemarituzumab (FPA144) is a monoclonal antibody against FGFR2 isoform B, which prevents ligand interaction and induces cell mediated cytotoxicity, potentially inhibiting proliferation and promoting apoptosis in cancer cells expressing FGFR2 isoform B (J Clin Oncol 32, 2014 (suppl; abstr e15074, PMID: 31094225, PMID: 32167861). | |
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov). |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 over exp | gastric adenocarcinoma | predicted - sensitive | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin | Phase II | Actionable | In a Phase II trial (FIGHT), the addition of Bemarituzumab (FPA144) to mFOLFOX6 treatment resulted in improved progression-free survival (9.5 months vs 7.4 months, HR=0.68, p=0.073) that did not reach statistical significance, and improved overall survival (not reached vs 12.9 months, HR=0.58, p=0.027) compared to mFOLFOX6 plus placebo in gastric or gastroesophageal junction adenocarcinoma patients with overexpression of FGFR2b (PMID: 36244398; NCT03694522). | 36244398 |
| FGFR2 over exp | gastroesophageal adenocarcinoma | predicted - sensitive | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin | Phase II | Actionable | In a Phase II trial (FIGHT), the addition of Bemarituzumab (FPA144) to mFOLFOX6 treatment resulted in improved progression-free survival (9.5 months vs 7.4 months, HR=0.68, p=0.073) that did not reach statistical significance, and improved overall survival (not reached vs 12.9 months, HR=0.58, p=0.027) compared to mFOLFOX6 plus placebo in gastric or gastroesophageal junction adenocarcinoma patients with overexpression of FGFR2b (PMID: 36244398; NCT03694522). | 36244398 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03694522 | Phase II | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) | Completed | USA | TUR | ROU | POL | ITA | HUN | GBR | FRA | ESP | DEU | BEL | AUS | 6 |
| NCT05052801 | Phase III | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) | Active, not recruiting | USA | TUR | SWE | ROU | POL | NOR | LVA | LTU | ITA | ISR | IRL | HUN | GRC | FRA | EST | ESP | DNK | CZE | CAN | BRA | BGR | BEL | AUS | ARG | 13 |
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