Kikuchi, Eiji https://orcid.org/0000-0002-1624-6676
Van der Heijden, Michiel S.
Valderrama, Begoña P.
Gupta, Shilpa
Bedke, Jens
Shin, Sang Joon
Li, Jian-Ri
Guo, Jun
Danchaivijitr, Pongwut
Kanesvaran, Ravindran
Park, Se Hoon
Su, Wen-Pin
Kandori, Shuya
Bae, Woo Kyun
Wong, Alvin
Gorla, Seema
Bavle, Abhishek
Yu, Xuesong
Lu, Yi-Tsung
Powles, Thomas
Clinical trials referenced in this document:
Documents that mention this clinical trial
Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39.
https://doi.org/10.1200/jco.2024.42.16_suppl.4563
Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
https://doi.org/10.1200/jco.2024.42.16_suppl.4502
Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39.
https://doi.org/10.1200/jco.2024.42.16_suppl.4562
Advances in diagnosis and treatment of bladder cancer
https://doi.org/10.1136/bmj-2023-076743
Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
https://doi.org/10.1200/jco.2024.42.23_suppl.108
Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma
https://doi.org/10.1007/s10147-025-02950-8
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer
https://doi.org/10.1136/jitc-2021-002552
Enfortumab vedotin (EV) in combination with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC): Subgroup analyses results from EV-302, a phase 3 global study.
https://doi.org/10.1200/jco.2024.42.4_suppl.lba530
EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
https://doi.org/10.1200/jco.2025.43.5_suppl.664
Funding for this research was provided by:
The study was funded by Astellas Pharma Inc., Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Seagen Inc., which was acquired by Pfizer Inc in December 2023
Article History
Received: 16 September 2025
Accepted: 16 December 2025
First Online: 21 January 2026
Declarations
:
: Eiji Kikuchi: Consulting fees from Astellas, AstraZeneca, Ferring, Janssen, Chugai, Merck BioPharma, and MSD; and payment for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Astellas, AstraZeneca, Janssen, Merck BioPharma, MSD, Bristol Myers Squibb, Chugai, Nippon Kayaku, Eisai, Bayer, Kyorin, and Takeda. Michiel S. Van der Heijden: Consulting fees from Astellas, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Janssen, MSD, and Pfizer; funding for investigator-led research from Bristol Myers Squibb, Roche, AstraZeneca, 4SC, and MSD/Merck; and is a steering committee member for Bristol Myers Squibb, AstraZeneca, MSD, Seagen, and Janssen. Begoña P. Valderrama: Consulting fees from AAA, Almirall Pharma, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, EUSA Pharmaceuticals, Ipsen, MSD, Pfizer, and Recordati; and travel funding from Astellas and Bristol Myers Squibb. Shilpa Gupta: Consulting fees from Astellas, Bayer, Bristol Myers Squibb, EMD Serono, Foundation Medicine, Genzyme, Gilead, Loxo Oncology, Merck, Pfizer, and Seattle Genetics; honoraria from Bristol Myers Squibb, Gilead, and Seattle Genetics; stocks/shares from BioNTech, Moderna, and Nektar Therapeutics; travel grant from EMD Serono; and is a member of data safety monitoring board for Protara. Jens Bedke: Consulting fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, Janssen, Merck KGaA, Merck Sharp & Dohme Oncology, Pfizer, and Roche; investigator for Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, MSD, Nektar, Pfizer, Roche, and Seagen; payment for participation in speakers bureaus for Apogepha, Bristol Myers Squibb, Ipsen, Merck KGaA, Merck Sharp & Dohme Oncology, Roche, Pfizer, and Seattle Genetics; support for attending meetings and/or travel from Merck and Ipsen; participation in a data safety monitoring board/advisory board for MSD and Pfizer; and is Vice-Chairman of the European Association of Urology RCC Guideline. Sang Joon Shin: No relevant financial or non-financial interests to disclose. Jian-Ri Li: Honoraria from Merck, MSD, Ono, and AstraZeneca; participated in speakers bureaus and received consulting fees from Merck, MSD, and Ono; research funding from Taichung Veterans General Hospital, Roche, Bayer, and AstraZeneca; and support for attending meetings and/or travel from MSD and Merck. Jun Guo: Consulting fees and others from Bayer, Novartis, MSD, Roche, Shanghai Junshi Biosciences, Simcere Pharmaceutical Group, and Oriengene. Pongwut Danchaivijitr: Honoraria from MSD, AstraZeneca, Astellas, and BMS; and support for attending meetings and/or travel from MSD. Ravindran Kanesvaran: Honoraria from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Johnson & Johnson, Ipsen, MSD, Merck, and Pfizer; support for attending meetings and/or travel from AstraZeneca and Merck; and is a member of data safety monitoring board for Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Johnson & Johnson, Ipsen, MSD, Merck, and Pfizer. Se Hoon Park: No relevant financial or non-financial interests to disclose. Wen-Pin Su: No relevant financial or non-financial interests to disclose. Shuya Kandori: Honoraria from Bristol Myers Squibb. Woo Kyun Bae: No relevant financial or non-financial interests to disclose. Alvin Wong: Payment for participation in advisory boards for Astellas, BMS, Ipsen, and MSD. Seema Gorla: Employee of Astellas Pharma Inc. Abhishek Bavle: Employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. Xuesong Yu: Employee of Pfizer and may own stocks/shares. Yi-Tsung Lu: Employee of Pfizer and may own stocks/shares. Thomas Powles: Consulting fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; travel funding from AstraZeneca, Ipsen, MSD, Pfizer, and Roche; research grant from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; and other/honoraria from Mashup Ltd and Gilead.