Benzinga | Jan 15, 2021 06:58AM EST

Five Prime Therapeutics Highlights Presentation Of Phase 2 FIGHT Trial Results At ASCO; Says All three Efficacy Endpoints (PFS, OS and ORR) Met Pre-Specified Statistical Significance

* All three efficacy endpoints (PFS, OS and ORR) in the FIGHT Phase 2 trial met pre-specified statistical significance

* 2021 priorities for the bemarituzumab program include collaborating with regulatory agencies on next steps, initiating a global Phase 3 trial in gastric and GEJ cancers and evaluating bemarituzumab in other epithelial cancers that overexpress FGFR2b

* Results presented today in a late-breaking oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Virtual Annual Symposium

* Five Prime to host webcast and conference call today at 1:30pm PST / 4:30pm EST

Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Trial results were presented in a late-breaking oral presentation today by UCLA Health's Zev Wainberg, M.D., at the 2021 ASCO Gastrointestinal Cancers Virtual Annual Symposium (ASCO GI). The ASCO GI presentation slides are available on the company's website.

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 United States, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo arm.

The Phase 2 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.

"Systemic chemotherapy is the standard of care for this deadly and aggressive form of gastric cancer. We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. "The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b."

"The Phase 2 FIGHT clinical trial results validate our pioneering work on the role of FGFR2b overexpression in gastric cancer, and we're excited about the implications of this new scientific understanding for other cancers," said Helen Collins, M.D., Five Prime's Executive Vice President and Chief Medical Officer. "With these data in hand, we plan to continue to collaborate with regulatory agencies on next steps, initiate a global Phase 3 trial in gastric cancer and begin studying bemarituzumab in other epithelial cancers that overexpress FGFR2b."