Phase III KEYNOTE-045 trial of Keytruda (pembrolizumab) meets primary endpoint in advanced urothelial cancer- Merck Inc

Merck has announced that the phase III 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. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early. 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.

KEYNOTE-045 is a randomized, pivotal, phase III study (ClinicalTrials.gov, NCT02256436) evaluating Keytruda monotherapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in the treatment of patients with metastatic or locally advanced or unresectable (inoperable) urothelial cancer that has recurred or progressed following platinum-based chemotherapy. The co-primary endpoints are overall survival (OS) and progression-free survival (PFS); secondary endpoints are overall response rate (ORR), duration of response (DOR), and safety. The study randomized 542 patients to receive Keytruda (200 mg every three weeks) or investigator-choice of paclitaxel (175 mg/m2 every three weeks), docetaxel (75 mg/m2 every three weeks), or vinflunine (320 mg/m2 every three weeks).