Amgen Announces Positive Phase 3 FORTITUDE-101 Results for Bemarituzumab in Gastric Cancer

Amgen today announced positive results from the Phase 3 FORTITUDE-101 trial evaluating bemarituzumab, an anti-FGFR2b antibody, in patients with FGFR2b-overexpressing gastric or gastroesophageal junction (GEJ) cancer. The trial met its primary endpoint of overall survival, demonstrating a statistically significant improvement compared to chemotherapy alone. The median OS was 19.2 months for bemarituzumab plus chemotherapy versus 13.5 months for chemotherapy alone. Bemarituzumab targets FGFR2b, which is overexpressed in approximately 30% of gastric cancers. These results support regulatory submissions for bemarituzumab in FGFR2b-overexpressing gastric cancer.