First release of Phase III KEYNOTE-045 study with pembrolizumab in bladder cancer

Results from the pivotal KEYNOTE-045 study investigating the use of pembrolizumab, an anti-PD-1 therapy, in patients with advanced bladder (urothelial) cancer previously treated with platinum-containing chemotherapy were presented at the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting, the first publicly presented findings from this study.

As previously announced, says Merck & Co (NYSE: MRK), which markets the drug under the trade name Keytruda, pembrolizumab was superior to investigator-choice chemotherapy for the primary endpoint of overall survival (OS) in this Phase III study, and was stopped early. Specifically, there was a 27% reduction in the risk of death in patients treated with pembrolizumab compared to chemotherapy (OS, HR = 0.73, p-value: 0.0022).

“The improved overall survival for patients receiving pembrolizumab in this trial are clinically significant and could impact how physicians consider treating patients with previously treated advanced urothelial cancer,” said Dr Roger Dansey, senior vice president, oncology late-stage development, MSD Research Laboratories. “These data add to the growing body of evidence from our clinical development program for pembrolizumab in a range of cancers, including advanced urothelial cancer."