Data from Pharmawand - Curated by EPG Health - Date added 16 April 2018
Merck Inc announced findings from the Phase III EORTC1325/KEYNOTE-054 trial investigating Keytruda (pembrolizumab) 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. The RFS benefit was also seen regardless of BRAF mutation status (HR=0.64 [99% CI, 0.42-0.96] for patients with wild-type BRAF status; HR=0.57 [99% CI, 0.37-0.89] for patients with mutant BRAF status).
As previously announced, Merck is working to submit data from EORTC1325/KEYNOTE-054 to regulatory agencies in the U.S. and around the world. These results are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #10526), with simultaneous publication in The New England Journal of Medicine.
See: "Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma" Alexander M.M. Eggermont et al. New England Journal of Medicine, April 15, 2018 DOI: 10.1056/NEJMoa18023570>0>