Amgen and Zai Lab’s Gastric Cancer Trial Hits Survival Goal

Amgen and Zai Lab announced that their Phase III FORTITUDE-101 trial met its primary endpoint, showing improved overall survival (OS) for bemarituzumab plus chemotherapy (mFOLFOX6) in patients with unresectable, locally advanced, or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. The benefit was observed in patients with FGFR2b overexpression (≥10% tumor cells with 2+/3+ staining) who are also HER2-negative.

The placebo-controlled, double-blind study enrolled 547 participants across 300 sites in 37 countries as a first-line treatment. Secondary endpoints include overall response rate (ORR) and progression-free survival (PFS). Enhanced ocular monitoring was included due to prior safety concerns.

Zai Lab supported the trial and holds rights in Greater China. Bemarituzumab has received breakthrough therapy designation in China, and another Phase III trial combining it with nivolumab is ongoing, with results expected in late 2025.

01-07-2025