Merck's Phase 3 Keynote-045 Trial Of Keytruda Meets Primary Endpoint
(RTTNews) - Merck (MRK), known as MSD outside the United States and Canada, Thursday announced that the phase 3 Keynote -045 trial investigating the use of Keytruda, an anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival.
The company said the Keytruda was 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.
The safety profile of Keytruda was consistent with that observed in previously reported studies involving patients with advanced urothelial cancer.
According to 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. Keynote -045 is a randomized, pivotal, phase 3 study evaluating as a monotherapy compared to investigator-choice chemotherapy.