Positive Phase III results for Amgen’s bemarituzumab

30 June 2025

US biotech major Amgen (Nasdaq: AMGN) today announced the Phase III FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis.

Bemarituzumab plus chemotherapy demonstrated a statistically-significant and clinically-meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing.

The positive results vindicate Amgen’s acquisition of Five Prime Therapeutics for $1.9 billion, along with bemarituzumab, back in 2021.

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