Subgroup analysis of real-world efficacy of enfortumab vedotin in patients with metastatic/locally advanced urothelial carcinoma from a European database.

• DOI: 10.1200/jco.2024.42.16_suppl.e16562
• Publication Date: 2024-06-06T17:50:18Z
• Authors: Christopher Darr; Niklas Klümper; Thomas Büttner; Nina Holzwarth; Nadine Biernath; Alexander Höllein; Guenter Niegisch; Daniel Seidl; Analena Handke; Pia Paffenholz; Katrin Schlack; Richard Cathomas; Eva Erne; Severine Banek; Robert Tauber; Jozefina Casuscelli; Anna Katharina Seitz; Boris A. Hadaschik; Viktor Grünwald; Stefanie Zschaebitz
• Keywords: Subgroup analysis; Metastatic Urothelial Carcinoma

e16562 Background: Enfortumab vedotin (EV) is an antibody drug conjugate targeting Nectin-4. It was approved by EMA/FDA in patients (pts) with metastatic/ locally advanced urothelial cancer post platinum and immune check point inhibitors (ICI) following the results of EV-301 trial. We report updated efficacy data EV a large European cohort real-world pts (GUARDIANS consortium) treated hospitals private practices. Methods: Retrospective were collected from 25 German Swiss practices for who received EV. Objective responses evaluated local investigators according to Response Evaluation Criteria Solid Tumors version 1.1. Cox proportional hazard model used analyze risk patterns. Correlation assessed using spearmen’s rank correlation coefficient. Progression-free survival (PFS) overall (OS) estimated Kaplan-Meier method. Results: identified 188 (32.4% female) median age 66 yrs (range 31-89; 22.3% ≥ 75 yrs). Median OS (mOS) 12.0 months (mo) (95% CI 9.65-14.35) PFS (mPFS) 7.0 mo 5.43-8.57). Overall response rate 46.3% (partial remission: 42.0%, complete 4.3%). follow up 11 (IQR: 6.0-17.0 mo). Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1/ 2-4/ unknown 75/14/11%. With decreasing ECOG-PS ≥2, there also decrease 4.95 (95 3.0-8.3; p<0.001) 2.1 1.14-3.92), resulting significant Spearman coefficant death 0.31, -0.36 -0.31 (p<0.001). line 3 3-4). Bellmunt Risk Score (BRS) >1 prior initiation significantly predicts poorer 3.3 1.82-5.72, 1.9 (65 1.15-3.25, p=0.013), respectively. Regarding metastases localization, liver bone involvement correlated 1.3 0.9-2.1; p=0.01) 1.5 1.01-2.36; p=0.04). In addition Upper Urinary Tract showed 1.4 0.89-2.19; p=0.027). Prior definitive intervention demonstrated improvement 0.6 0.32-1; p=0.048). ICI-therapy, IC or CPS did influence neither nor PFS. Limitations are retrospective design short follow-up. Conclusions: Anti-tumor activity including difficult-to-treat subgroups comparable pivotal Frail pts. have higher progression. BRS predictive indicator treatment heavily pretreated patients. Liver OS. The prognosis after therapy connection should be investigated further future.