OBR OncologyFDA Approves Enfortumab Vedotin Combo for Advanced Urothelial Carcinoma

The decision was based on the findings of the open-label, multi-cohort, multicenter, phase 1b/2 clinical trial EV-103/KEYNOTE-869. Patients who participated in the study and were included in the current analysis had locally advanced or metastatic disease, were ineligible for cisplatin-containing chemotherapy, and had not previously received systemic therapy. The primary efficacy outcome measures for the study were the objective response rate (ORR) and duration of response (DoR), which were determined by an independent central review using RECIST v1.1. The ORR for the 121 patients treated with the combination was 68%, with 12% having a complete response. The median DoR for dose escalation was 22 months for two cohorts but not for a third.