Overview
Bemarituzumab (anti-FGFR2b) is an Fc-optimized monoclonal antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy alone in patients with FGFR2b positive, HER2 negative frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population with FGFR2b overexpression or mutation which accounts for 30% of HER2 negative patients. Based on this, the FDA granted bemarituzumab Breakthrough Therapy Designation. Zai Lab has an exclusive license for bemarituzumab in greater China, and we collaborated with Five Prime (subsequently acquired by Amgen) on the Phase 2 FIGHT trial in greater China. A global phase 3 clinical study for FGFR2b overexpression in first-line patients with advanced gastric or GEJ cancer is ongoing (with China’s participation).
Mechanism of Action
Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells.