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Bristol-Myers Squibb Company (NYSE:BMY) today reported results from the Phase 3 randomized, double-blind clinical trial (Study 043) comparing Yervoy 10 mg/kg (ipilimumab) (n=399) to placebo (n=400) following radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with docetaxel. The study’s primary endpoint of overall survival (OS) did not reach statistical significance (HR = 0.85; 95% CI = 0.72-1.00; p = 0.053). However, anti-tumor activity was observed across some efficacy endpoints, including progression free-survival. These data will be presented at the 2013 European Cancer Congress in an oral session on September 28 (Abstract # 2850).
Treatment-related adverse events were common, with most being immune-related (irAEs), and were managed using standard Yervoy management protocols. Grade ≥3 irAEs in the Yervoy and placebo arms, respectively, were gastrointestinal (GI; 18% vs. 1%), liver (5% vs. 1%), endocrine (2% vs. 1%), and dermatologic (1% vs. 0%). The incidence of drug-related death was 1%.
“While we are disappointed that the primary endpoint of overall survival was not met, we remain encouraged that results in this advanced population support the potential role of immunotherapies for prostate cancer. We are committed to continuing our development of Yervoy in prostate cancer,” said
Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “Immuno-oncology is a rapidly evolving treatment modality and findings from this study provide important scientific insights that can be applied to current and future studies of Yervoy as well as our broad pipeline of immunotherapies in development.”
Yervoy 3 mg/kg monotherapy is currently approved in more than 40 countries for the treatment of patients with unresectable or metastatic melanoma.
“Although the study did not meet its primary endpoint, clinical activity was observed in this Phase 3 trial with a suggestion of greater activity in those with less advanced castration-resistant prostate cancer,” said W.R. Gerritsen, MD, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands. “These results offer important insights for ongoing and future studies of Yervoy in prostate cancer, including a second large trial of Yervoy in patients with less advanced disease.”