Merck & Co. announced Friday that a Phase III study of Keytruda (pembrolizumab) in patients with previously treated advanced urothelial cancer met the primary endpoint of overall survival (OS). The company noted that in the KEYNOTE-045 trial, the anti-PD-1 therapy was superior compared to investigator's choice of chemotherapy.
According to Merck, Keytruda is the first immunotherapy to show improved OS compared with chemotherapy in urothelial cancer. The company added that based on a pre-specified interim analysis, the study's independent Data Monitoring Committee recommended that the trial be stopped early.
In the study, 542 patients with previously treated advanced urothelial cancer were randomised to treatment with Keytruda or investigator's choice of therapy, namely paclitaxel, docetaxel or vinflunine. In addition to the co-primary endpoints of OS and progression-free survival, secondary goals of the trial included overall response rate, duration of response and safety.
Roger Perlmutter, president of Merck Research Laboratories, said "the results...represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer." Merck indicated that data from the study will be submitted for presentation at a future research conference.
Keytruda, which amassed $314 million in revenue in the second quarter, is currently approved in a number of markets for the treatment of advanced melanoma, treatment-experienced patients with PD-L1-positive non-small-cell lung cancer (NSCLC) and recurrent or metastatic head and neck squamous cell carcinoma. Most recently, the FDA accepted for priority review a filing seeking approval of Keytruda to include the first-line treatment of patients with advanced NSCLC whose tumours express PD-L1, granting the application a target action date of December 24 (for related analysis, read ViewPoints: Could festive cheer crown 2016 as the year of Keytruda?).
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