Zai Lab announces FORTITUDE-101 clinical trial meets primary endpoint

Zai Lab (ZLAB) announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy met its primary endpoint of overall survival 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 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 testing. The most common treatment-emergent adverse events in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from the trial will be shared at a future medical meeting. Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025.