Biotech Values

[jbog]

Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA®, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Study results showed KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in the overall study population (HR=0.57 [98.4% CI, 0.43-0.74]; p<0.0001). For the primary endpoint of RFS in the overall study population, the one-year RFS rate was 75.4 percent (95% CI, 71.3-78.9) for KEYTRUDA compared to 61.0 percent (95% CI, 56.5-65.1) for placebo. For the co-primary endpoint of RFS in patients whose tumors were considered PD-L1 positive, KEYTRUDA demonstrated significantly prolonged RFS compared to placebo (HR=0.54; 95% CI, 0.42-0.69; p<0.0001). The safety profile of KEYTRUDA was consistent with what has been seen in previous trials among patients with advanced melanoma. These results are being presented today for the first time in the opening plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #10526), with simultaneous publication in The New England Journal of Medicine.


https://www.businesswire.com/news/home/20180415005048/en/Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Reduced-Risk-Disease-Recurrence