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 | ITA | GBR | FRA | ESP | DEU | BEL | AUS 10
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) Recruiting USA | ITA | FRA | ESP | CAN | BEL | AUS 30


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