Merck's Keytruda hits endpoints in Phase III advanced bladder cancer trial

21 October 2016

US pharma giant Merck & Co (NYSE: MRK) says that the Phase III KEYNOTE-045 trial investigating the use of its cancer drug Keytruda (pembrolizumab) met the primary endpoint of overall survival (OS) in advanced bladder cancer.

In this trial, Keytruda was superior compared to investigator choice chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

“The results of Keytruda-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer,” said Dr Roger Perlmutter, president, Merck Research Laboratories, adding: “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”

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