Amgen...announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay

...bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT). Of 910 1L GC pts whose tumors were evaluated 275 (30%) were FGFR2b+. Improved efficacy was observed across all 3 endpoints (PFS, OS, ORR) with increasing levels of overexpression of FGFR2b on tumor cells.

The trial compared mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144)...in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer....Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027...Overall response rate (ORR) improved by 13.1% (p=0.106).