Merck Sharp and Dohme calls early end to successful Keytruda bladder cancer trial

Merck Sharp and Dohme has halted a phase III trial assessing its drug Keytruda as a treatment for advanced bladder cancer.

The KEYNOTE-045 trial investigating the use of the anti-PD-1 therapy in patients with previously treated advanced urothelial cancer has met its primary endpoint of overall survival, with Keytruda proving superior compared to investigator-choice chemotherapy.

Based on a pre-specified interim analysis, an independent data monitoring committee has recommended that the trial be stopped early. Full results from the study will be presented at an upcoming medical meeting.

This means Keytruda is now the first immunotherapy to demonstrate improved overall survival compared with chemotherapy in urothelial cancer.

Dr Roger Perlmutter, president of Merck Research Laboratories, said: "The results of KEYNOTE-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer."

The Keytruda clinical development programme has included over 30 tumour types in more than 360 clinical trials, including nearly 200 studies combining Keytruda with other cancer treatments.

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