Real-world data of enfortumab vedotin in patients with advanced urothelial cancer in Spain: The ENFANTS-GUARD study.

Abstract

Background: Urothelial cancer (UC) is the fifth most common cancer in Spain. Advanced UC (aUC) is an aggressive disease with a high mortality rate. Enfortumab vedotin (EV) has been recently approved in Spain for the treatment of adult patients (pts) with aUC, although real-world data remain limited. We aim to describe clinical characteristics, treatment, outcomes and safety of EV treatment in routine practice. Methods: This retrospective observational study included pts with aUC who received EV across 17 hospitals in Spain. Demographic, clinical, treatment-related (efficacy and safety) and healthcare resource utilization data were collected. Progression-free survival (PFS), overall survival (OS) and time to treatment failure (TTF) were measured from EV initiation. Survival was estimated using the Kaplan–Meier method. Investigator-assessed observed response rate (ORR) was assessed for evaluable pts with scans after ≥1 cycle EV. Adverse events (AEs) were recorded and graded by CTCAE 5.0. Hospital admissions during EV treatment were collected. Results: A total of 195 pts were included. Median age was 71 years, 76.9% were male. 49.7% had localized disease at diagnosis with a median time to metastasic progression of 17.9 months. The primary tumor site was bladder in 82.1%, and upper urinary tract in 15.9%. 76.3% had pure urothelial, 22.2% variant differentiation and 3 (1.5%) non-urothelial carcinoma. ECOG PS was 0,1 and ≥2 in 25.1%, 63.6% and 11.3% pts, respectively. Patients received a median of 2 prior lines of systemic treatment. The most common immediate prior treatments were PD-1/L1 inhibitor monotherapy (41.0%) and chemotherapy (13.9%), while 27.7% received these in combination or as maintenance. Median follow-up was 34.4 months. Median PFS, OS and TTF were 7.4 [5.87-8.89], 12.8 [11.2-14.3] and 6.2 [5.54-7.97] months, respectively. ORR was 52.1%. EV related AEs occurred in 68.7% of pts, with ≥ grade 3 in 20.9%. Peripheral sensory neuropathy and rash were the most frequent AEs. 29.7% pts required hospitalization during EV treatment, with a median stay of 7 days. Baseline characteristics are summarized in Table 1. Conclusions: In this multicenter cohort, EV demonstrated efficacy and safety consistent with clinical trials, supporting its role as a standard option for previously treated patients with aUC. Despite the overall clinical burden, EV achieved meaningful disease control with favorable ORR and TTF outcomes in routine practice.