Merck trial studying Keytruda in advanced bladder cancer meets primary endpoint and stops early

Keytruda is the first immunotherapy to show improved overall survival compared with chemotherapy in urothelial cancer.

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

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies involving patients with advanced urothelial cancer. Results from KEYNOTE-045 will be presented at an upcoming medical meeting.

The Keytruda clinical development program includes more than 30 tumour types in more than 360 clinical trials, including nearly 200 trials that combine Keytruda with other cancer treatments. For genitourinary cancers, Merck has the largest immuno-oncology clinical development program in bladder cancer, with 27 trials underway involving Keytruda as monotherapy and in combination, including four registration-enabling studies.