Five Prime Therapeutics has reported that the Phase II clinical trial of its cabiralizumab (FPA008) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) missed the primary endpoint in advanced pancreatic cancer patients.
Cabiralizumab is an investigational antibody designed to block the CSF-1 receptor. In preclinical models and clinical studies, the drug showed the ability to inhibit the activation and survival of monocytes and macrophages.
Bristol-Myers Squibb obtained the rights to cabiralizumab as part of an exclusive global licence and collaboration agreement signed in October 2015.
The randomised Phase II trial assessed cabiralizumab plus Opdivo with or without chemotherapy in approximately 160 locally advanced or metastatic pancreatic cancer patients whose disease has progressed during or following one line of chemotherapy.
The primary endpoint of the trial was median progression-free survival (mPFS), while secondary outcomes included objective response rate, median duration of response, and overall survival rate.
Analysis of data showed that the combination, with or without chemotherapy, failed to meet the primary endpoint. No new safety signals were reported during the trial.
Five Prime Therapeutics executive vice-president and chief medical officer Helen Collins said: “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 randomised, controlled Phase II trial.
“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 II clinical trial.”
The company added that Bristol-Myers Squibb has no near term plans to further sponsor cabiralizumab’s development but will continue to support some of the drug’s ongoing trials.
Five Prime Therapeutics and Bristol-Myers Squibb signed a clinical collaboration agreement in 2014 to evaluate the combination of Opdivoand FPA008 in six tumour types.