KEYNOTE-716: adjuvant pembrolizumab versus placebo in completely resected stage IIB or IIC melanoma
A year of pembrolizumab after surgery for stage IIB or IIC melanoma reduced recurrences and distant metastases by about 35 to 40 percent, extending adjuvant immunotherapy to node-negative but thick or ulcerated melanomas.
Overview
Phase 3 placebo-controlled trial of 976 patients aged 12 and over with resected stage IIB or IIC melanoma randomised to pembrolizumab or placebo for up to 17 cycles.
At the first interim analysis, recurrence-free survival favoured pembrolizumab (hazard ratio 0.65); at longer follow-up, 36-month recurrence-free survival was 76.2 versus 63.4 percent and distant metastasis-free survival hazard ratio 0.59. Immune-related adverse events, mainly endocrine, occurred in about a third.
- Recurrence-free survival hazard ratio 0.65 at first analysis; 36-month rate 76.2 percent vs 63.4 percent.
- Distant metastasis-free survival hazard ratio 0.59.
Adjuvant pembrolizumab is approved for stage IIB and IIC melanoma, though the absolute benefit and lack of survival data make observation a reasonable alternative after discussion.
- No overall survival benefit shown; most patients would not have relapsed.
- Permanent endocrine side effects in a minority.
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