KEYNOTE-716
Extended adjuvant immunotherapy to thick node-negative melanomas, a group whose risk of relapse rivals stage III.
RFS and distant metastasis-free survival improved (FDA approval December 2021 for stage IIB/IIC). Five-year follow-up (ESMO 2025) reported sustained RFS and DMFS benefit; OS not yet mature. The absolute benefit is smaller than in stage III and the trial reignited debate about over-treatment given that most stage II patients never relapse.
Setting
Resected stage IIB or IIC melanoma: adjuvant pembrolizumab 1 year vs placebo
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
RFS and DMFS improved; 5-year benefit sustained (ESMO 2025).
Reported
2021
Enrolled
976
Replication
CheckMate 76K (nivolumab in stage IIB/IIC) showed a concordant RFS benefit.