Merck announced that the phase 3 keynote-045 trial investigating the use of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS).
In this trial, Keytruda was superior compared to investigator choice chemotherapy, said Merck in its announcement issued on October 21. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.
“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.”, continued Dr Perlmutter.
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, announced Merck.
The Keytruda clinical development program includes more than 30 tumor 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.