CheckMate-76K Efficacy Data
Three-year follow-up data from the CheckMate-76K trial
showed a continued RFS* benefit with adjuvant OPDIVO
in Stage IIB/IIC melanoma1,2†
Adapted from Product Monograph and Long GV, et al.1,2
CI: confidence interval; HR: hazard ratio; NR: not reached; Q4W: every 4 weeks; RFS: recurrence-free survival.
* RFS, assessed by the investigator, was defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death from any cause, whichever occurs first.
† CheckMate-76K was a phase III randomized, double-blind trial enrolling patients with completely resected Stage IIB or IIC melanoma. Patients were randomized (2:1) to receive OPDIVO (n=526) administered as an intravenous infusion over 30 minutes at 480 mg every 4 weeks or placebo (n=264) and were treated for 1 year or until disease recurrence or unacceptable toxicity. Randomization was stratified by the American Joint Committee on Cancer (AJCC) 8th edition T Stage (T3b vs. T4a vs. T4b); 3-year results.
‡ Based on stratified Cox proportional hazard model.
§ Based on log-rank test stratified by the AJCC 8th edition T stage at study entry. P-value is derived from the log-rank test. The corresponding O’Brien-Fleming efficacy boundary significance level at the interim analysis is 0.024.