On February 18, 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 that Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint (Press release, Five Prime Therapeutics, FEB 18, 2020, View Source [SID1234554429]). While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase 2 trial.
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"Pancreatic cancer is a difficult disease to treat, and unfortunately the combination of cabiralizumab and Opdivo with and without chemotherapy did not show any meaningful benefit over standard of care chemotherapy in this randomized, controlled Phase 2 trial," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "We are disappointed by this outcome and appreciate the participation of the investigators, staff, patients, caregivers, and our development partner who all contributed to the conduct and completion of this Phase 2 clinical trial."
The multi-arm, randomized, controlled Phase 2 clinical trial (NCT03336216) enrolled approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.