On March 13, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported the publication of results from the phase 1 escalation and expansion study of bemarituzumab in patients with advanced solid tumors and FGFR2b-selected gastroesophageal adenocarcinoma in the digital edition of the Journal of Clinical Oncology (Press release, Five Prime Therapeutics, MAR 13, 2020, View Source [SID1234555555]).
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The purpose of the phase 1 trial was to evaluate the safety, pharmacokinetics, and preliminary activity of single-agent bemarituzumab in patients with FGFR2b-overexpressing GEA. Seventy-nine patients were enrolled in the trial and no dose-limiting toxicities were reported. Bemarituzumab was well tolerated and the most frequent treatment-related adverse events (TRAEs) were fatigue, nausea, and dry eye. The overall response rate observed in this study of advanced-stage patients with high FGFR2b-overexpressing GEA was 17.9% (95% CI 6.1% to 36.9%) with five of 28 patients achieving a confirmed partial response.
"Gastroesophageal adenocarcinoma is the third most common cause of cancer death worldwide and the median overall survival of patients who present with advanced disease remains dismal at only 11 months," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "The results of this study underscore the potential of bemarituzumab evaluation as a novel treatment option for patients with advanced gastric and gastroesophageal junction cancer."
"Monotherapy activity of bemarituzumab and its lack of significant overlapping toxicities with standard chemotherapeutic agents suggest that combining bemarituzumab with chemotherapy may potentially benefit patients in the front-line setting whose GEA tumors overexpress FGFR2b," said Daniel Catenacci, M.D. and Associate Professor, the University of Chicago Medical Center and Biological Sciences.
Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial in the front-line treatment setting.