Bristol Myers Squibb 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).
This trial was open to all comers regardless of PD-L1 status. The RFS HR of 0.42 is quite impressive and should lead to another approved indication for Opdivo in the adjuvant setting.
BMY announced the success of this trial on 9/15/22 (#msg-169956859), but the details were disclosed for the first time today.
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