Enfortumab vedotin (EV) has been recommended for the treatment of patients with metastatic urothelial carcinoma (mUC), both in the post-chemotherapy/immunotherapy setting and as a first-line option in combination with pembrolizumab. This study aims to evaluate the oncological outcomes of EV in a real-world clinical setting.

We conducted a retrospective analysis of patients with metastatic urothelial carcinoma who received EV at two medical centers. Data regarding objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (AEs) were collected and analyzed.

A total of 78 patients were included in the study. Among them, 56 patients (71.8%) had upper tract urothelial carcinoma. Prior chemotherapy and immune checkpoint inhibitors had been administered to 57 (73.0%) and 44 (56.4%) patients, respectively. A complete response (CR) was achieved in 9 patients (11.5%), while 18 patients (23.1%) had a partial response (PR). Primary progression was observed in 30 patients (38.5%). The median progression-free survival was 8 months, and the median overall survival was 12 months. In terms of adverse events, 64 patients (82.0%) experienced AEs of any grade. The most commonly reported AEs included skin rash or pruritus in 35 patients (44.9%), hyperglycemia in 11 patients (14.1%), peripheral neuropathy in 10 patients (12.8%), and fatigue in 6 patients (7.7%). No treatment-related adverse events greater than grade 3 were observed.

In our real-world cohort, the efficacy of EV was comparable to outcomes reported in clinical trials. Importantly, no severe (grade>3) adverse events were observed, indicating a favorable safety profile.