New Data Reinforce Benefits Of Bristol Myers's Opdivo In Earlier Stages Of Melanoma

Bristol Myers Squibb Co BMY announced results from the Phase 3 CheckMate -76K trial evaluating adjuvant Opdivo (nivolumab) for up to 12 months versus placebo in 790 patients with completely resected stage IIB or IIC melanoma.
Opdivo as an adjuvant therapy demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo.
Opdivo reduced the risk of recurrence or death by 58% versus placebo. Twelve-month RFS rates for Opdivo were 89% versus 79% for placebo.
Related: Bristol Myers' Opdivo Combo Treatment Scores European Approval For Skin Cancer Setting.
The RFS benefit was observed across predefined subgroups in the trial, including the T category and disease stage.
Twelve-month RFS rates by stage for patients who received Opdivo were 93% in stage IIB (versus 84% in placebo) and 84% in stage IIC (versus 72% with placebo).
The safety profile of Opdivo was consistent with that seen in previously reported studies, and no new safety signals were observed at the time of the analysis.
Grade 3/4 treatment-related adverse events (TRAEs) were 10% in the Opdivo arm and 2% in the placebo arm.
TRAE-related discontinuation was 15% for those in the Opdivo arm and 3% for those in the placebo arm.
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