KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK) said that the first results from the Phase 3 KEYNOTE-716 trial, in which adjuvant treatment with the company's anti-PD-1 therapy Keytruda, 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.
At the first interim analysis, Keytruda reduced the risk of disease recurrence or death by 35% 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% of patients on Keytruda had recurrence or died compared with 16.8% of patients on placebo, with fewer distant recurrences with Keytruda versus placebo.
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