Merck announced the first results from the Phase 3 KEYNOTE-716 trial, in which adjuvant treatment with KEYTRUDA, Merck’s anti-PD-1 therapy, showed a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS), the trial’s primary endpoint, compared to placebo in patients with resected high-risk stage II melanoma; KEYTRUDA is the first anti-PD-1 therapy to demonstrate this. At the first interim analysis, KEYTRUDA reduced the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46–0.92]; p=0.00658) compared to placebo. Median RFS had not been reached for either group at the time of this analysis. After 14.4 months follow-up, 11.1% (n=54/487) of patients on KEYTRUDA had recurrence or died compared with 16.8% (n=82/489) of patients on placebo, with fewer distant recurrences with KEYTRUDA (4.7%, n=23/487) versus placebo (7.8%, n=38/489).