Publication details

Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2<sup>EV</sup> Study

Authors	FIALA Ondrej MASSARI Francesco BASSO Umberto GIANNATEMPO Patrizia GRANDE Enrique BUTI Sebastiano MYINT Zin W UGO De Giorgi PICHLER Renate GRILLONE Francesco URUN Yuksel CALABRO Fabio BOURLON Maria T GALLI Luca KANESVARAN Ravindran ROVIELLO Giandomenico KUCHARZ Jakub RIZZO Mimma PARK Se Hoon CERBONE Linda SERONT Emmanuel MESSINA Carlo MOLINA-CERRILLO Javier SANTINI Daniele YANO Akihiro INCORVAIA Lorena CATALANO Martina PINTO Alvaro FORMISANO Luigi SOARES Andrey FACCHINI Gaetano FORNARINI Giuseppe POPRACH Alexandr REBUZZI Sara Elena NASSO Cecilia SPINELLI Gian Paolo MARTIN Angel STELLATO Marco TURAL Deniz AURILIO Gaetano EPSTEIN Ilana CARROZZA Francesco MONTEIRO Fernando Sabino Marques BENEDETTI Giovanni BUCHLER Tomas ORTEGA Cinzia ZAKOPOULOU Roubini BATTELLI Nicola PORTA Camillo BELLMUNT Joaquin GUPTA Shilpa SANTONI Matteo
Year of publication	2024
Type	Article in Periodical
Magazine / Source	Targeted Oncology
MU Faculty or unit	Faculty of Medicine
Citation
Web	https://link.springer.com/article/10.1007/s11523-024-01099-0
Doi	http://dx.doi.org/10.1007/s11523-024-01099-0
Keywords	Enfortumab Vedotin; Platinum chemotherapy; Avelumab maintenance; Metastatic urothelial carcinoma; ARON-2EV study; Immunotherapy; Bladder cancer treatment; Urothelial carcinoma management; Advanced cancer therapies
Description	Background Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy. Objective The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study. Patients and Methods The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Results Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade >= 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade >= 3 diarrhea and 4% of grade >= 3 hyperglycemia. Conclusions The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.