By Fineline Cube 
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that its Phase III FORTITUDE-101 study for bemarituzumab has met the primary endpoint of overall survival (OS) at the pre-specified interim analysis.
Drug Background
Bemarituzumab, an investigational FGFR2b inhibitor, was licensed from Five Prime Therapeutics, Inc. (later acquired by Amgen) in 2017 for development and commercialization in Mainland China, Hong Kong, Macau, and Taiwan. The drug received Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE) for the treatment of FGFR2b-positive gastric and gastroesophageal junction (GEJ) cancer.
Clinical Trial Results
The FORTITUDE-101 study evaluated the efficacy and safety of bemarituzumab combined with chemotherapy (mFOLFOX6) in first-line unresectable locally advanced or metastatic FGFR2b-overexpressing, HER2-negative gastric or GEJ cancer. Results demonstrated a significant improvement in overall survival (OS) in FGFR2b-positive gastric cancer patients compared to placebo plus mFOLFOX6.-Fineline Info & Tech