Bristol-Myers Squibb announced results from its Phase 3 study (CA-184-043) comparing Yervoy (ipilimumab) 10mg/kg to placebo 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.
CA-184-043 is a randomized, double-blind clinical trial in which patients received bone-directed radiation therapy after being randomly assigned 1:1 to receive Yervoy 10 mg/kg (n=399) or placebo (n=400) every three weeks for a total of four doses. Eligible patients received maintenance treatment every three months.
In the intent-to-treat population, the median OS was 11.2 months for Yervoy and 10 months for placebo (HR=0.85; 95% CI=0.72–1.00; P=0.053). The one- and two-year survival rates for Yervoy vs. placebo were 47% vs. 40%, and 26% vs. 15%, respectively. 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 seen by declines of ≥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.
Yervoy is already approved for the treatment of unresectable or metastatic melanoma. It is currently being studied in Phase 3 trials for patients with mCRPC who have not received prior cytotoxic treatment (Study 095) and in adjuvant melanoma and non-small cell lung cancer.
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