Five Prime fired up by top-line Phase II data readout on bemarituzumab

USA-based biotech Five Prime Therapeutics (Nasdaq: FPRX) on Tuesday announced positive top-line results from the global, randomized, double-blind placebo-controlled Phase II FIGHT trial, with the news sending the shares roaring up 364% to $24.80 in heavy volume after-hours.

The trial compared mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144), a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer. The drug is partnered with China’s Zai Lab (Nasdaq: ZLAB)

“These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade,” said Dr Helen Collins, Five Prime’s executive vice president and chief medical officer, noting: “Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide.