Distant metastasis-free survival with adjuvant pembrolizumab versus placebo for resected stage III melanoma

The multinational phase 3 EORTC/KEYNOTE-054 trial randomized patients after resection of stage III melanoma for one year to pembrolizumab or placebo. The superiority of pembrolizumab over placebo for the endpoint recurrence-free survival at 15-month median follow-up has been published in 2018 (HR 0.57; p<0.001). A secondary end point was distant metastasis-free survival. At an overall median follow-up of 42.3 months, the 3.5 year DMFS was 65.3% with pembrolizumab versus 49.4% with placebo (HR 0.60; p<0.0001) in the ITT population, and 66.7% versus 51.6% (HR 0.61; p<0.0001) in the population of patients with PD-L1 positive tumors. The RFS remained longer in the pembrolizumab group than in the placebo group (59.8% versus 41.4% at 3.5 years; HR 0.59; 95% CI 0.49-0.70).