Short-term outcomes of enfortumab vedotin plus pembrolizumab as a first-line treatment for advanced urothelial carcinoma: Real-world use in multicenter cohort regardless of cisplatin eligibility

This study aimed to evaluate the short-term efficacy and safety of enfortumab vedotin plus pembrolizumab (EV + P) as a first-line systemic therapy for patients with advanced urothelial carcinoma (UC) in real-world practice, with a focus on cisplatin (CDDP) eligibility. Seventy-six patients who received EV + P treatment for advanced UC at 13 institutions between November 2024 and March 2025 were retrospectively included in this study. We collected the clinical characteristics and treatment data of the patients and assessed treatment response, progression-free survival (PFS), and adverse events (AEs). Patients were divided into two groups based on CDDP eligibility, and both efficacy and safety were compared between the groups. The median observation period was 5.25 (range, 0.72–10.06) months. Complete response (CR) was achieved in 6 (7.9%) patients receiving EV + P, partial response (PR) in 40 (52.6%), stable disease (SD) in 20 (26.3%), and progressive disease (PD) in 10 (13.2%). Six-month and median PFS rates were 80.6% and not reached, respectively. AEs of any grade and grade ≥ 3 occurred in 59 (77.6%) and 25 (32.9%) patients, respectively. The most frequently observed AE was skin disorders, which occurred in 33 (43.4%) patients; no grade 5 AEs were observed. Efficacy and safety did not differ between CDDP-ineligible and CDDP-eligible patients. In conclusion, the short-term efficacy of EV + P treatment seemed comparable to that in previous reports, and the safety profile was acceptable, regardless of CDDP eligibility.