Multinational phase 3 study of pembrolizumab versus placebo after nephrectomy for ccRCC

The multinational phase 3 KEYNOTE-564 study evaluated pembrolizumab versus placebo after nephrectomy for intermediate-high risk or high risk ccRCC. At the first prespecified interim analysis, the primary endpoint of DFS was met (HR 0.68; p=0.0010) with estimated DFS rate at 24 months of 77.3% with pembrolizumab versus 68.1% with placebo. The OS HR was 0.54 (p=0.0164); the p –value did not cross the statistical hypothesis testing boundary and additional follow-up is planned for OS. The authors conclude that the results support pembrolizumab as a potential new standard of care for RCC in the adjuvant setting.