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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 5 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 that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (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 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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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


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