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Yervoy (Ipilimumab) Disappoints in Prostate Cancer Trial
Drug fails to meet phase III endpoint (September 12)
Disappointing results have been reported from a phase III randomized, double-blind clinical trial comparing Yervoy (ipilimumab, Bristol-Myers Squibb) 10 mg/kg with placebo following radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who had received prior treatment with docetaxel.
The study’s primary endpoint of overall survival (OS) did not reach statistical significance (hazard ratio = 0.85; P = 0.053). However, antitumor activity was observed across some efficacy endpoints, including progression free-survival.
The new data will be presented Sept. 28 at the 2013 European Cancer Congress.
In the intent-to-treat population, the median OS was 11.2 months for ipilimumab and 10.0 months for placebo. The 1- and 2-year survival rates for ipilimumab versus placebo were 47% versus 40%, and 26% versus 15%, respectively.
Yervoy (ipilimumab) is currently indicated for the treatment of unresectable or metastatic melanoma.
Ipilimumab is a recombinant human monoclonal antibody that blocks the cytotoxic T-lymphocyte antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80 and CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation.
Source: Bristol-Myers Squibb; September 12, 2014.