Five Prime updates bemarituzumab FIGHT data

US biotech Five Prime Therapeutics (Nasdaq: FPRX) has updated Phase II FIGHT data in gastric cancer - including subgroup data, safety data, and immediate next steps – which were presented as an oral late-breaker at ASCO Gastrointestinal Cancers Virtual Annual Symposium (ASCO: GI) on Friday.

These data validate the importance FGFR2b overexpression and the potential of bemarituzumab plus chemo as a frontline therapy in gastric and GEJ cancers, the company said.

The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the USA, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo cohort.

The Phase II trial met all three efficacy endpoints and demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and overall response rate (ORR). Additional analysis showed a positive correlation between benefit and the percentage of FGFR2b+ tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.