key papersKey paper
CheckMate 76K: adjuvant nivolumab in resected stage IIB or IIC melanoma
Adjuvant nivolumab for a year after surgery cut the risk of recurrence by more than half in stage IIB and IIC melanoma, confirming the benefit seen with pembrolizumab in the same setting.
Overview
Phase 3 placebo-controlled trial of 790 patients with completely resected stage IIB or IIC melanoma randomised 2:1 to nivolumab or placebo for 12 months.
Twelve-month recurrence-free survival was 89.0 versus 79.4 percent (hazard ratio 0.42), with benefit across subgroups and a distant metastasis-free survival hazard ratio of 0.47; treatment-related grade 3 to 4 adverse events occurred in 10.3 percent.
Randomised controlled trialChanged practice790 participants
Authors
Kirkwood JM, Del Vecchio M, Weber J, et al.
Published
Nature Medicine, 2023
Findings
- Twelve-month recurrence-free survival 89.0 percent vs 79.4 percent; hazard ratio 0.42.
- Distant metastasis-free survival hazard ratio 0.47.
What it means
Nivolumab is a second approved adjuvant option for stage IIB and IIC melanoma with the same trade-offs as pembrolizumab.
Caveats
- Short follow-up at primary analysis; no survival data.