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Real-World Outcomes of Enfortumab Vedotin and Pembrolizumab in Advanced Urothelial Carcinoma: A Multicenter Retrospective Analysis
Journal article   Peer reviewed

Real-World Outcomes of Enfortumab Vedotin and Pembrolizumab in Advanced Urothelial Carcinoma: A Multicenter Retrospective Analysis

Prateek Jain, Syed Arsalan Ahmed Naqvi, Nikita Tripathi, Japneet K. Oberoi, Muhammad Abdullah Humayun, Yousef Zakharia, Jacob J. Orme, Adam Kase, Dan S. Childs, Ruqin Chen, …
Clinical genitourinary cancer, Vol.23(6), 102453
12/2025
DOI: 10.1016/j.clgc.2025.102453
PMID: 41177680

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Abstract

Introduction Enfortumab vedotin plus pembrolizumab has emerged as a new standard of care for previously untreated patients with advanced urothelial carcinoma following the EV-302 trial. However, data on its efficacy and safety in routine clinical practice remain limited. Herein, we evaluated real-world clinical outcomes for patients with advanced urothelial carcinoma receiving the combination as first-line or subsequent-line therapy. Patients and Methods This retrospective cohort study included adults (≥18 years) with histologically confirmed bladder or upper tract urothelial carcinoma (other histologic type variants were also included), who initiated treatment with enfortumab vedotin-pembrolizumab therapy between May 2020 and December 2024 at the Mayo Clinic. Patients initiating therapy after December 2024 or with incomplete data were excluded. Patients were stratified by line of therapy: Cohort A included patients who received enfortumab vedotin-pembrolizumab as first-line therapy, and Cohort B included patients who received it as subsequent-line therapy. The primary endpoint was to estimate median progression-free survival in cohort A and cohort B. Results A total of 183 patients with advanced urothelial carcinoma treated with the enfortumab vedotin-pembrolizumab combination were included. The median age at treatment initiation was 71.9 years (IQR, 64.7–77.4). Most patients were male (71.0%) and white (90.7%). The median progression-free survival was 12.9 months (95% CI, 9.5–NE) in Cohort A and 9.3 months (95% CI, 6.3–NE) in Cohort B. This difference was not statistically significant (HR, 1.30; 95% CI, 0.83–2.04; P = 0.246). Treatment-related adverse events of any grade were reported in 93.4% of patients, with 30.6% experiencing Grade ≥3 AEs. Conclusion In this real-world cohort, enfortumab vedotin-pembrolizumab combination demonstrated meaningful clinical activity and manageable toxicity in both first-line and subsequent-line settings, consistent with results from the EV-302 trial. Microabstract: Evidence on the real-world efficacy of enfortumab vedotin–pembrolizumab in advanced urothelial carcinoma remains limited. In this retrospective study of 183 patients, the combination demonstrated a median progression-free survival of 12.9 months in first-line versus 9.3 months in subsequent-line settings, with no statistically significant difference across treatment lines. These findings support the regimen’s effectiveness in real-world practice.
 Enfortumab Vedotin-Pembrolizumab EV-Pembro Real-world evidence First-line therapy Metastatic Urothelial Carcinoma

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