The FDA has approved the combination regimen of Merck’s Keytruda (pembrolizumab) and Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) for the first-line treatment of locally advanced or metastatic urothelial carcinoma, the companies announced Monday.
This marks the first approved therapeutic regimen that combines a PD-1 blocker and an antibody-drug conjugate (ADC) in the U.S. in this indication, according to the press release.
Data from three cohorts of the Phase Ib/II KEYNOTE-869 (also called EV-103) trial supported the approval of the combination regimen. In the study, Keytruda plus Padcev led to a 68% objective response rate, with a complete and partial response rate of 12% and 55%, respectively.