Farmas USA

Five Prime soars 304% as bemarituzumab + chemo shows significant benefit

• Five Prime Therapeutics (NASDAQ:FPRX) surges 304% on positive topline results from the global Phase 2 FIGHT trial, enrolling 155 patients.
• The trial compared bemarituzumab (FPA144) in combination with mFOLFOX6 chemotherapy to placebo combined with mFOLFOX6 in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), HER2-negative front-line advanced gastric or gastroesophageal junction (GEJ) cancer.
• All three efficacy endpoints in the FIGHT trial – progression-free survival (PFS), overall survival (OS) and Overall response rate (ORR) achieved pre-specified statistical significance.
• Median PFS improved from 7.4 months in the placebo arm to 9.5 months in the bemarituzumab arm. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073.
• Median OS improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027.
• ORR improved by 13% (p=0.106).
• The incidence of all-grade adverse events was comparable in the treatment and control arms (100% vs. 98.7%, respectively), as were serious adverse events (31.6% vs. 36.4%) and deaths due to adverse events (6.6% vs. 5.2%).
• Despite the higher frequency of discontinuation of bemarituzumab (34.2%) compared to placebo (5.2%), all efficacy endpoints favored bemarituzumab.
• Trial may broaden the therapeutic potential of bemarituzumab in more cancer types.
• The company will complete a full evaluation of the available Phase 2 data and share results at an upcoming medical conference.
• Today’s announcement contains initial top-line results from the primary analysis based on a prespecified number of events.
• Five Prime granted an exclusive license to Zai Lab (NASDAQ:ZLAB) to develop and commercialize bemarituzumab in Greater China, and latter collaborated with FPRX on the Phase 2 FIGHT trial in the region.