GU Cancers 2026 | RC48001: disitamab vedotin in HER2-expressing advanced urothelial cancer
Tyler Stewart, MD, University of California, San Diego, CA, discusses the Phase II RC48001 trial (NCT04879329) of disitamab vedotin monotherapy in previously treated HER2-expressing locally advanced or metastatic urothelial cancer. The study assessed two cohorts with varying HER2 expression levels. The antibody-drug conjugate demonstrated promising antitumor activity with a manageable safety profile, supporting further evaluation of this targeted approach in patients with HER2-expressing urothelial cancer who have progressed on prior systemic therapies. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
Trastuzumab Deruxtecan is an antibody drug conjugate that targets HER2 and has an MMAE payload. This study has been looked at in some previous studies in China with objective response rates in around 50% and in combination with the checkpoint inhibitors in the frontline setting and muscle invasive setting. Here we see an international study of Trastuzumab Deruxtecan in a second-line setting in HER2 expressing metastatic urothelial carcinomas that have been previously treated...
Trastuzumab Deruxtecan is an antibody drug conjugate that targets HER2 and has an MMAE payload. This study has been looked at in some previous studies in China with objective response rates in around 50% and in combination with the checkpoint inhibitors in the frontline setting and muscle invasive setting. Here we see an international study of Trastuzumab Deruxtecan in a second-line setting in HER2 expressing metastatic urothelial carcinomas that have been previously treated. In this study, we saw objective response rates of around 50%, with CR rates of 16% to 18%, which are quite impressive. And this was really seen in the HER2 3+, and the HER2 2+, the 1+, was a little bit lower. Now, importantly to know is that the patients who were enrolled on this study could not have received an MMAE payload containing agent, and so patients could not have had Enfortumab Vedotin before. So, although this agent looks like it’s very effective for patients with urothelial carcinoma, it’s unclear how effective this will be in the post-Enfortumab Vedotin setting.
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