Merck announced October 21, 2016, that the phase III KEYNOTE-045 trial investigating the use of pembrolizumab (Keytruda), the company’s anti–PD-1 (programmed cell death protein 1) therapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival. In this trial, pembrolizumab was superior compared to investigator's choice of chemotherapy. Based on a prespecified interim analysis, an independent Data Monitoring Committee 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 Roger M. Perlmutter, MD, PhD, President of Merck Research Laboratories. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”
The safety profile of pembrolizumab 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 ID: NCT02256436) evaluating pembrolizumab monotherapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in the treatment of patients with metastatic or locally advanced or unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy. The coprimary endpoints are overall survival and progression-free survival; secondary endpoints are overall response rate, duration of response, and safety.
The study randomized 542 patients to receive pembrolizumab (200 mg every 3 weeks) or investigator's choice of paclitaxel (175 mg/m2 every 3 weeks), docetaxel (75 mg/m2 every 3 weeks), or vinflunine (320 mg/m2 every 3 weeks).
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