Merck has decided to end the phase 3 KEYNOTE-991 trial due to futility.
The trial (ClinicalTrials.gov Identifier: NCT04191096) was designed to compare pembrolizumab plus enzalutamide and androgen deprivation therapy (ADT) with placebo plus enzalutamide and ADT in patients with metastatic hormone-sensitive prostate cancer.
A planned interim analysis of the trial showed that pembrolizumab plus enzalutamide and ADT did not improve overall survival or radiographic progression-free survival, the study’s primary endpoints.
In addition, although no new safety signals were identified, a higher incidence of grade 3-5 adverse events was observed in the pembrolizumab arm than in the control arm.
Data from KEYNOTE-991 will be presented at an upcoming meeting.
Merck announces KEYNOTE-991 trial evaluating Keytruda® (pembrolizumab) plus enzalutamide and androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer to stop for futility. News release. January 25, 2023. https://www.businesswire.com/news/home/20230124006084/en/Merck-Announces-KEYNOTE-991-Trial-Evaluating-KEYTRUDA%C2%AE-pembrolizumab-Plus-Enzalutamide-and-Androgen-Deprivation-Therapy-in-Patients-With-Metastatic-Hormone-Sensitive-Prostate-Cancer-to-Stop-for-Futility.
This article originally appeared on MPR