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

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.
  • Price Action: BMY shares closed 0.84% down at $71.74 on Wednesday.
Posted In: BriefsBiotechLarge CapNewsHealth CareGeneral