Amgen's Gastric Cancer Drug Improves Survival In Phase 3, Notes Ocular Side Effects

Amgen Inc (NASDAQ:AMGN) on Monday released data from the Phase 3 FORTITUDE-101 trial of first-line bemarituzumab plus chemotherapy (mFOLFOX6).

The study 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 for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive.

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Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year.

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye.

While ocular events were consistent with ...