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Melanoma drug Yervoy did not reach primary endpoint in prostate cancer study
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A phase 3 study comparing ipilimumab with placebo in treating patients with advanced metastatic castration-resistant prostate cancer did not reach statistical significance for overall survival, according to Bristol-Myers Squibb.
Ipilimumab (Yervoy), a recombinant, human monoclonal antibody that blocks the cytoxic T-lymphocyte antigen-4, currently is approved as 3 mg/kg monotherapy in more than 40 countries for treating patients with unresectable or metastatic melanoma, the press release said. It was approved by the FDA for such indication in 2011.
A randomized, double blind trial compared ipilimumab 10 mg/kg (n=399) to placebo (n=400) after radiation in patients with advanced metastatic castration-resistant prostate cancer who had been treated with docetaxel. Statistical significance was not reached for overall survival (HR=0.85; 95% CI, 0.72-1), the release said. Anti-tumor activity was observed across some efficacy endpoints and included progression-free survival.
Adverse events, most immune related (irAE), were commonly reported. Gastrointestinal (18% vs. 1%), liver (5% vs. 1%), endocrine (2% vs. 1%) and dermatologic (1% vs. 0%) irAEs of grade 3 or greater were more common among ipilimumab patients than placebo patients. Drug-related death had a 1% incidence.
“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,” Brian Daniels, MD, senior vice president, global development and medical affairs, Bristol-Myers Squibb, said in the release.
Data on the study is scheduled for presentation Sept. 28 at the European Cancer Congress in Amsterdam.