Five Prime starts dosing in trial evaluating FPA144 in Gastric Cancer in Japan
Five Prime Therapeutics announced the company has initiated dosing in its Phase 1 clinical trial of FPA144, an anti-FGF receptor 2b antibody, in patients with advanced gastric and gastroesophageal cancer in Japan."Gastric cancer is the sixth most common cancer by incidence globally and we estimate approximately 10% of gastric cancer patients have tumors that have FGFR2 gene amplification or overexpress FGFR2b, which are associated with significantly lower survival rates than the gastric cancer patient population as a whole," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "Moreover, the observed incidence of gastric cancer is higher in Asian populations than in other populations. We believe FPA144 represents a potentially promising treatment option for this targeted patient population with high unmet need. "The number of metastatic gastric and gastroesophageal junction cancer patients eligible for front-line treatment in Japan is approximately 73,000 patients per year. Five Prime estimates approximately 7,300 patients per year could be biomarker-positive and eligible for FPA144 treatment with front-line chemotherapy. The Phase 1 open-label, dose-finding study will evaluate the safety, tolerability, pharmacokinetics and recommended dose of FPA144 in approximately 6 to 12 Japanese patients with advanced gastric or gastroesophageal cancer. Completion of this Phase 1 trial is intended to enable the inclusion of Japanese patients in potential future Phase 3 trials of FPA144 in gastric cancer. Internal non-clinical data demonstrates additivity of FPA144 to standard-of-care chemotherapy regimens. Five Prime plans to initiate a global pivotal trial of FPA144 for front-line treatment of FGFR2b-overexpressing or FGFR2 gene-amplified metastatic gastric and gastroesophageal junction cancer in combination with chemotherapy in 2018.