Bristol-Myers reports Phase 3 data on Yervoy in melanoma, says boosts survival
Bristol-Myers Squibb announced "superior efficacy" with Yervoy 10 mg/kg versus placebo on all survival endpoints in the Phase 3 trial CA184-029 evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection. In the study, Yervoy compared with placebo significantly improved overall survival, a secondary endpoint, with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group. Distant metastasis-free survival, a secondary endpoint, was also significantly improved versus placebo and had five-year DMFS rates of 48.3% and 38.9% in the Yervoy and placebo groups, respectively. The median DMFS was 48.3 months with Yervoy versus 27.5 months with placebo. In this updated five-year analysis, the recurrence-free survival -- the primary endpoint -- benefit observed previously with Yervoy was maintained. Updated five-year results demonstrated RFS remained significantly longer for Yervoy versus placebo, with a median RFS of 27.6 months versus 17.1 months, respectively. The safety profile remained consistent with the initial analysis, with no new deaths or safety signals. These data were featured during the 2016 European Society for Medical Oncology Congress Press Program and simultaneously published in The New England Journal of Medicine.