Disitamab vedotin in urothelial carcinoma patients: a clinical trial perspective from ARON working group

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.

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.'

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.