Association between enfortumab vedotin and renal function in metastatic urothelial carcinoma: A multicenter retrospective study in Japan

Abstract Purpose: Patients with metastatic urothelial carcinoma (mUC) often experience impaired renal function because of tumor invasion, nephroureterectomy, and chemotherapy. Enfortumab vedotin (EV) has been approved in Japan as a third-line treatment for advanced UC. In this study, we aimed to assess renal function changes in patients with mUC receiving EV therapy. Methods: We retrospectively analyzed renal function changes and clinical outcomes in 63 patients with mUC who received EV following platinum-based chemotherapy and immune checkpoint inhibitors. Data were collected from five institutions in Japan from September 2021 to September 2024. Results: The median baseline estimated glomerular filtration rate (eGFR) was 44.1 mL/min/1.73 m². Chronic kidney disease stage remained unchanged in 54% of patients, upstaging in 17%, and downstaging in 29%. The median change rate in eGFR was 2.6%. The median overall survival was 12.0 months in the eGFR ≥ 45 mL/min/1.73 m² group and 15.4 months in the eGFR < 45 mL/min/1.73 m² group. The objective response rate was 45% in the eGFR ≥ 45 mL/min/1.73 m² group and 34% in the eGFR < 45 mL/min/1.73 m² group. Adverse events (AEs) of any grade occurred in 84% of patients with eGFR ≥ 45 and 69% of those with eGFR < 45, with grade ≥3 AEs reported in 7% and 13% patients, respectively. Conclusions: EV did not significantly impair renal function in patients with mUC. Comparable efficacy and safety were observed regardless of baseline eGFR, supporting the feasibility of EV in patients with impaired renal function.