Results from CheckMate -76K Demonstrate Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival
Data reinforce the benefits of Opdivo in earlier stages of melanoma
Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -76K trial, in which Opdivo (nivolumab) as an adjuvant therapy demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage IIB or IIC melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS); Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001). Twelve-month RFS rates for Opdivo were 89% (95% CI: 86-92) versus 79% (95% CI: 74-84) for placebo. The RFS benefit was observed across predefined subgroups in the trial, including T category and disease stage. These results are being presented as late-breaking data at the 2022 Society for Melanoma Research (SMR) Annual Meeting taking place October 17-20, 2022, during a plenary session on October 19 in Edinburgh, Scotland.
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