CAMBRIDGE, Mass.– Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has announced promising topline results from its Phase 3 FORTITUDE-101 trial, showing that its experimental therapy bemarituzumab, when combined with chemotherapy, significantly improved overall survival in patients with advanced FGFR2b-positive gastric cancer.
The trial met its primary endpoint at a pre-specified interim analysis, demonstrating that bemarituzumab plus standard chemotherapy (mFOLFOX6) outperformed chemotherapy alone in patients with unresectable, locally advanced, or metastatic gastric or gastroesophageal junction (G/GEJ) cancer who overexpress the FGFR2b protein and are HER2-negative.
“This is the first FGFR2b-targeted therapy to show a statistically and clinically significant survival benefit in a Phase 3 trial for first-line treatment of this patient population,” said Dr. Rafael Amado, President and Head of Global R&D at Zai Lab. “The FORTITUDE-101 results mark a major step forward and open the door to potentially redefining the standard of care for FGFR2b-positive gastric cancer.”
Gastric cancer remains a major global health burden, ranking as the fifth leading cause of cancer-related death worldwide, with nearly a million new cases annually. In China alone, more than 350,000 people are diagnosed with the disease each year, with late-stage patients facing a five-year survival rate of less than 10%. Currently, no targeted therapies for FGFR2b overexpression in gastric cancer are approved in China.
Bemarituzumab, developed under Zai Lab’s license for Greater China, has already received Breakthrough Therapy designation from the China Center for Drug Evaluation. The company plans to submit the drug for regulatory approval in China soon, following these encouraging results.
While treatment-related side effects were largely consistent with previous studies, common adverse events observed in over 25% of patients included reduced visual acuity, corneal effects, anemia, nausea, and neutropenia. Ocular side effects were more frequent and severe in the bemarituzumab treatment arm compared to the control group.
Further details from the FORTITUDE-101 trial will be presented at an upcoming medical conference.
In addition, a separate Phase 3 study combining bemarituzumab with chemotherapy and the immunotherapy drug nivolumab is currently underway, with results expected in the second half of 2025.
