A Phase 3 clinical trial, KEYNOTE-045, assessing Merck's (NYSE:MRK) PD-1 inhibitor KEYTRUDA (pembrolizumab) in treatment-experienced patients with advance urothelial cancer has been stopped early after the independent Data Monitoring Committee determined that the study met its primary endpoint of overall survival (OS).
KEYNOTE-045 is a 542-subject, randomized study evaluating KEYTRUDA as monotherapy compared to investigator choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced/unresectable urothelial cancer that has progressed following platinum-based chemo. The co-primary endpoints are OS and progression-free survival (PFS). Secondary endpoints are overall response rate (ORR), duration of response (DOR) and safety. Participants were randomized to receive either 200 mg of KEYTRUDA every three weeks or investigator-choice chemo every three weeks.
Detailed results will be submitted for presentation at a future medical conference.
KEYTRUDA is Merck's fastest growing drug. It is currently approved for the treatment of melanoma, head and neck cancer and lung cancer. It is in clinical development for the treatment of more than 30 tumor types in more than 360 clinical trials.
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