Disitamab vedotin in urothelial carcinoma patients: a clinical trial perspective from ARON working group
INTRODUCTION: In recent years, studies have demonstrated that in urothelial carcinoma (UC), the rate of HER-2 protein overexpression (immunohistochemistry 2+ and 3+) ranges from 18.1% to 36%, and the rate of HER-2 gene amplification reaches 10%-23%. The advent of HER-2-targeted antibody-drug conjugates and immune checkpoint inhibitors has reshaped the treatment landscape of advanced urothelial carcinoma. AREAS COVERED: In the current paper, we discuss the role of disitamab vedotin as an innovative anticancer therapy in UC patients, with a specific focus on available evidence and ongoing clinical trials. A literature search of PubMed/MEDLINE, Embase, Scopus, and ClinicalTrials.gov (through May 2026) was performed using the terms 'disitamab vedotin,' 'RC48-ADC,' and 'urothelial carcinoma.' EXPERT OPINION: As ADC-based strategies continue to expand in UC, further studies will be needed to better understand how DV should be integrated with other anticancer approaches in this setting, particularly in terms of patient selection and treatment sequencing.
Authors
- Francesco Ciccimarra (ORCID: https://orcid.org/0009-0009-7321-0950)
- Anas Zayed
- Cinthia Gauna (ORCID: https://orcid.org/0009-0001-5669-8431)
- Gerardo Cazzato (ORCID: https://orcid.org/0000-0003-0325-4316)
- Kannan Sridharan (ORCID: https://orcid.org/0000-0003-3811-6503)
- Matteo Santoni (ORCID: https://orcid.org/0000-0001-7340-6173)
- Concetta Calabrò (ORCID: https://orcid.org/0009-0008-6915-0820)
- Olivier Kabiriko Mukuku (ORCID: https://orcid.org/0000-0001-6902-7023)
- Aly‐Khan A. Lalani (ORCID: https://orcid.org/0000-0002-9907-9112)
- Veronica Mollica (ORCID: https://orcid.org/0000-0002-5169-3631)
- Tibor Szarvas (ORCID: https://orcid.org/0000-0002-6321-0799)
- Jure Murgić (ORCID: https://orcid.org/0000-0001-8152-0494)
- Francesco Massari (ORCID: https://orcid.org/0000-0001-6476-6871)
- Raffaella Massafra (ORCID: https://orcid.org/0000-0001-8588-261X)
- María Tereza Nieto-Coronel (ORCID: https://orcid.org/0000-0002-5606-6434)
- Alessandro Rizzo (ORCID: https://orcid.org/0000-0003-1990-0490)
- Oronzo Brunetti (ORCID: https://orcid.org/0000-0002-7014-6828)
- Loredana Palermo
- Mario Della Mura (ORCID: https://orcid.org/0009-0009-5116-2484)
- Chiara Paciolla (ORCID: https://orcid.org/0009-0008-4276-6991)
- Anna Milella
Institutions
- Semmelweis University (HU)
- King Hussein Cancer Center (JO)
- Institut Supérieur de Technique Médicale (CD)
- Sisters of Charity Hospital (HR)
- Istituto Tumori Bari (IT)
- Instituto Nacional de Câncer - INCA (BR)
- Instituto Nacional del Cáncer (CL)
- Ospedale di Macerata
- ARON Research Foundation ETS (IT)
- Arabian Gulf University (BH)
- University of Bari Aldo Moro (IT)
- University of Duisburg-Essen (DE)
- University of Bologna (IT)
- McMaster University (CA)
Publication Details
- Journal
- Expert Review of Clinical Pharmacology
- Published
- 2026-10-04
- DOI
- https://doi.org/10.1080/17512433.2026.2744573
- Primary Topic
- Bladder and Urothelial Cancer Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00