Merck Inc., provides update on phase III trial KEYNOTE-641 of pembrolizumab and enzalutamide to treat metastatic castration-resistant prostate cancer.
23 February 2023- - Merck Inc., (known as MSD outside of the United States and Canada), provided updates on two Phase III trials, KEYNOTE-641 and KEYNOTE-789
Merck is discontinuing the Phase III KEYNOTE-641 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) based on the recommendation of an independent Data Monitoring Committee. At an interim analysis, Keytruda in combination with enzalutamide and ADT did not demonstrate an improvement in radiographic progression-free survival (rPFS) or overall survival (OS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT, and crossed a pre-specified futility boundary for OS. Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment.