Yervoy fails Phase III trial for metastatic Prostate Cancer
Bristol-Myers Squibb Company reported results from the Phase III 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).
Median progression-free survival favored Yervoy over placebo (HR=0.70; 95% CI = 0.61-0.82) as did prostate-specific antigen (PSA) response rates, as evidenced by declines of greater-than or equal to 50% in evaluable patients (13.1% vs. 5.3%, respectively). Pre-specified subset analyses suggest that Yervoy may be more active in patients with indicators for less advanced disease.
The Phase III program for Yervoy includes Study 095, an ongoing Phase III randomized double-blind trial comparing the efficacy of Yervoy 10 mg/kg versus placebo in patients with mCRPC who have not received prior cytotoxic treatment.
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