KEYNOTE-054 (EORTC 1325): adjuvant pembrolizumab versus placebo in resected stage III melanoma
A year of pembrolizumab after surgery for stage III melanoma cut the risk of recurrence by 43 percent compared with placebo, the first placebo-controlled proof that adjuvant PD-1 blockade works.
Overview
Phase 3 placebo-controlled trial of 1,019 patients with completely resected stage III melanoma randomised to pembrolizumab or placebo for one year.
Twelve-month recurrence-free survival was 75.4 versus 61.0 percent (hazard ratio 0.57), consistent across PD-L1 and BRAF subgroups; five-year recurrence-free survival was 55.4 versus 38.3 percent and distant metastasis-free survival was also improved, with grade 3 or higher immune-related events in 7.1 percent.
- Twelve-month recurrence-free survival 75.4 percent vs 61.0 percent; hazard ratio 0.57.
- Five-year recurrence-free survival 55.4 percent vs 38.3 percent.
Adjuvant pembrolizumab is a standard for resected stage III melanoma, with subsequent trials extending it to stage II and to the neoadjuvant setting.
- Overall survival benefit not demonstrated, as placebo patients could receive pembrolizumab at relapse.
Similar pages
not linked directly; found by shared links- Key paperMSLT-II: completion lymph node dissection or observation for sentinel-node metastasis in melanoma
Shares Stage III melanoma (after surgery), New England Journal of Medicine.
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