Merck and the European Organisation for Research and Treatment of Cancer 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.
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.
“The EORTC is very pleased to have collaborated with Merck on this important study which showed a significant recurrence-free survival benefit across all stage III melanoma,” said Alexander Eggermont, study chair, director general at the Gustave Roussy Cancer Institute, professor of oncology, University of Paris-Saclay.
