Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and
Pembrolizumab in Metastatic Urothelial Carcinoma : A
Multicenter Real-World Analysis of the ARON-2EV Cohort

J 2025

Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort

FIALA, Ondrej; Francesco GRILLONE; Kazutoshi FUJITA; Enrique GRANDE; Patrizia GIANNATEMPO et al.

Basic information

Original name

Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort

Authors

Edition

EUROPEAN UROLOGY OPEN SCIENCE, AMSTERDAM, ELSEVIER, 2025, 2666-1691

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30204 Oncology

Country of publisher

Netherlands

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Impact factor

Impact factor: 4.500 in 2024

Marked to be transferred to RIV

Yes

Organization unit

Faculty of Medicine

Keywords in English

Urothelial cancer; Enfortumab vedotin; Pembrolizumab; ARON-2EV study; Clinical trial; NCT05290038

Abstract

In the original language

Background and objective: Enfortumab vedotin (EV) has demonstrated efficacy in metastatic urothelial carcinoma (mUC) following treatment with platinum-based chemotherapy (PBC) and PD-1/PD-L1 inhibitors, including pembrolizumab (PEM). Our aim was to assess real-world clinical outcomes of EV inpatients with mUC previously treated with PBC followed by pembrolizumab (PBC/PEM). Methods: ARON-2EV is an international, multicenter, retrospective study examining the real-world use of EV in patients with mUC. This analysis included 401 patients with mUC treated with EV following PBC/PEM. Primary endpoints were overall survival (OS), time on treatment (ToT), and the overall response rate (ORR). Secondary objectives included evaluation of clinical factors associated with outcomes and exploration of the impact of prior PEM outcomes. Statistical methods included Kaplan-Meier estimates, log-rank tests, Fisher's exact and v2 tests, Pearson's correlation coefficients, and Cox analyses. Key findings and limitations: Median OS was 12.3 mo (95% confidence interval [CI] 9.9-14.3), median ToT was 10.4 mo (95% CI 9.0-12.2), and the ORR was 45%. Prior response to PEM was significantly correlated with subsequent outcomes on EV. In the group who experienced progressive disease (PD) on prior PEM, the ORR was 35%. Major limitations are related to the retrospective study design. Conclusions: EV has consistent real-world efficacy in patients with mUC following sequential treatment with PBC/PEM. These results support the utility of EV in diverse clinical scenarios and suggest an association between prior PEM outcomes and subsequent EV efficacy. Patient summary : The ARON-2EV project is collecting real-world data for patients with metastatic cancer of the urinary tract who are being treated with a drug called enfortumab vedotin (EV) in multiple centers worldwide. Our results show that EV has consistent efficacy in these patients after previous treatment with platinum-based chemotherapy followed by pembrolizumab. The results also suggest an association between a patient's response to pembrolizumab and their subsequent response to EV. (c) 2025 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).

Cite

FIALA, Ondrej; Francesco GRILLONE; Kazutoshi FUJITA; Enrique GRANDE; Patrizia GIANNATEMPO; Tarek TAHA; Zin W MYINT; Thomas BUTTNER; De Liano Alfonso GOMEZ; Ravindran KANESVARAN; Gaetano FACCHINI; Akihiro YANO; Luigi FORMISANO; Alexandr POPRACH; Vincenza CONTEDUCA; Alina PIRSHTUK; Hana STUDENTOVA; Jindrich KOPECKY; Enrico SAMMARCO; Augusto MOTA; Lorena INCORVAIA; Cecilia NASSO; Michele MAFFEZZOLI; Aruni GHOSE; Andrey SOARES; Sebastiano BUTI; Fernando Sabino Marques MONTEIRO; Francesco MASSARI; Shilpa GUPTA; Joaquim BELLMUNT; Giuseppe Luigi BANNA and Matteo SANTONI. Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort. EUROPEAN UROLOGY OPEN SCIENCE. AMSTERDAM: ELSEVIER, 2025, vol. 82, December 2025, p. 111-120. ISSN 2666-1691. Available from: https://doi.org/10.1016/j.euros.2025.10.010.

@article{2537821,
   author = {Fiala, Ondrej and Grillone, Francesco and Fujita, Kazutoshi and Grande, Enrique and Giannatempo, Patrizia and Taha, Tarek and Myint, Zin W and Buttner, Thomas and Gomez, De Liano Alfonso and Kanesvaran, Ravindran and Facchini, Gaetano and Yano, Akihiro and Formisano, Luigi and Poprach, Alexandr and Conteduca, Vincenza and Pirshtuk, Alina and Studentova, Hana and Kopecky, Jindrich and Sammarco, Enrico and Mota, Augusto and Incorvaia, Lorena and Nasso, Cecilia and Maffezzoli, Michele and Ghose, Aruni and Soares, Andrey and Buti, Sebastiano and Monteiro, Fernando Sabino Marques and Massari, Francesco and Gupta, Shilpa and Bellmunt, Joaquim and Banna, Giuseppe Luigi and Santoni, Matteo},
   article_location = {AMSTERDAM},
   article_number = {December 2025},
   doi = {https://doi.org/10.1016/j.euros.2025.10.010},
   keywords = {Urothelial cancer; Enfortumab vedotin; Pembrolizumab; ARON-2EV study; Clinical trial; NCT05290038},
   language = {eng},
   issn = {2666-1691},
   journal = {EUROPEAN UROLOGY OPEN SCIENCE},
   title = {Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort},
   url = {https://www.sciencedirect.com/science/article/pii/S2666168325014405?pes=vor&utm_source=clarivate&getft_integrator=clarivate},
   volume = {82},
   year = {2025}
}

TY  - JOUR
ID  - 2537821
AU  - Fiala, Ondrej - Grillone, Francesco - Fujita, Kazutoshi - Grande, Enrique - Giannatempo, Patrizia - Taha, Tarek - Myint, Zin W - Buttner, Thomas - Gomez, De Liano Alfonso - Kanesvaran, Ravindran - Facchini, Gaetano - Yano, Akihiro - Formisano, Luigi - Poprach, Alexandr - Conteduca, Vincenza - Pirshtuk, Alina - Studentova, Hana - Kopecky, Jindrich - Sammarco, Enrico - Mota, Augusto - Incorvaia, Lorena - Nasso, Cecilia - Maffezzoli, Michele - Ghose, Aruni - Soares, Andrey - Buti, Sebastiano - Monteiro, Fernando Sabino Marques - Massari, Francesco - Gupta, Shilpa - Bellmunt, Joaquim - Banna, Giuseppe Luigi - Santoni, Matteo
PY  - 2025
TI  - Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort
JF  - EUROPEAN UROLOGY OPEN SCIENCE
VL  - 82
IS  - December 2025
SP  - 111-120
EP  - 111-120
PB  - ELSEVIER
SN  - 26661691
KW  - Urothelial cancer
KW  - Enfortumab vedotin
KW  - Pembrolizumab
KW  - ARON-2EV study
KW  - Clinical trial
KW  - NCT05290038
UR  - https://www.sciencedirect.com/science/article/pii/S2666168325014405?pes=vor&utm_source=clarivate&getft_integrator=clarivate
N2  - Background and objective: Enfortumab vedotin (EV) has demonstrated efficacy in metastatic urothelial carcinoma (mUC) following treatment with platinum-based chemotherapy (PBC) and PD-1/PD-L1 inhibitors, including pembrolizumab (PEM). Our aim was to assess real-world clinical outcomes of EV inpatients with mUC previously treated with PBC followed by pembrolizumab (PBC/PEM). Methods: ARON-2EV is an international, multicenter, retrospective study examining the real-world use of EV in patients with mUC. This analysis included 401 patients with mUC treated with EV following PBC/PEM. Primary endpoints were overall survival (OS), time on treatment (ToT), and the overall response rate (ORR). Secondary objectives included evaluation of clinical factors associated with outcomes and exploration of the impact of prior PEM outcomes. Statistical methods included Kaplan-Meier estimates, log-rank tests, Fisher's exact and v2 tests, Pearson's correlation coefficients, and Cox analyses. Key findings and limitations: Median OS was 12.3 mo (95% confidence interval [CI] 9.9-14.3), median ToT was 10.4 mo (95% CI 9.0-12.2), and the ORR was 45%. Prior response to PEM was significantly correlated with subsequent outcomes on EV. In the group who experienced progressive disease (PD) on prior PEM, the ORR was 35%. Major limitations are related to the retrospective study design. Conclusions: EV has consistent real-world efficacy in patients with mUC following sequential treatment with PBC/PEM. These results support the utility of EV in diverse clinical scenarios and suggest an association between prior PEM outcomes and subsequent EV efficacy. Patient summary : The ARON-2EV project is collecting real-world data for patients with metastatic cancer of the urinary tract who are being treated with a drug called enfortumab vedotin (EV) in multiple centers worldwide. Our results show that EV has consistent efficacy in these patients after previous treatment with platinum-based chemotherapy followed by pembrolizumab. The results also suggest an association between a patient's response to pembrolizumab and their subsequent response to EV. (c) 2025 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
ER  -

FIALA, Ondrej; Francesco GRILLONE; Kazutoshi FUJITA; Enrique GRANDE; Patrizia GIANNATEMPO; Tarek TAHA; Zin W MYINT; Thomas BUTTNER; De Liano Alfonso GOMEZ; Ravindran KANESVARAN; Gaetano FACCHINI; Akihiro YANO; Luigi FORMISANO; Alexandr POPRACH; Vincenza CONTEDUCA; Alina PIRSHTUK; Hana STUDENTOVA; Jindrich KOPECKY; Enrico SAMMARCO; Augusto MOTA; Lorena INCORVAIA; Cecilia NASSO; Michele MAFFEZZOLI; Aruni GHOSE; Andrey SOARES; Sebastiano BUTI; Fernando Sabino Marques MONTEIRO; Francesco MASSARI; Shilpa GUPTA; Joaquim BELLMUNT; Giuseppe Luigi BANNA and Matteo SANTONI. Efficacy of Enfortumab Vedotin After Platinum Chemotherapy and Pembrolizumab in Metastatic Urothelial Carcinoma : A Multicenter Real-World Analysis of the ARON-2EV Cohort. \textit{EUROPEAN UROLOGY OPEN SCIENCE}. AMSTERDAM: ELSEVIER, 2025, vol.~82, December 2025, p.~111-120. ISSN~2666-1691. Available from: https://doi.org/10.1016/j.euros.2025.10.010.

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