disitamab-vedotin

Overview

Disitamab vedotin (RC48) is a HER2-directed antibody-drug conjugate (ADC) carrying an MMAE (monomethyl auristatin E) payload. It is approved in China for HER2-overexpressing gastric cancer and is under global investigation for urothelial carcinoma and other HER2-expressing solid tumors. In the CALGB 90601 cfDNA biomarker study, disitamab vedotin is highlighted as a relevant HER2-directed ADC in metastatic urothelial carcinoma given the prognostic significance of ERBB2 cfDNA alterations.

Evidence in the corpus

  • In the CALGB 90601 cfDNA cohort (n=201 metastatic urothelial carcinoma patients receiving first-line gemcitabine/cisplatin ± bevacizumab), ERBB2 cfDNA alterations were detected in 14% of cases and were independently associated with shorter overall survival (multivariable HR 1.64, 95% CI 1.08–2.49; p=0.019). The authors specifically cite disitamab vedotin alongside trastuzumab deruxtecan as HER2-directed ADCs with response rates of 33–83% in ERBB2-altered mUC, positioning these genomic findings as adding clinical urgency to HER2-targeting strategies. PMID:40256659

Resistance mechanisms

  • Not characterized in this corpus.

Cancer types (linked)

  • BLCA — metastatic urothelial carcinoma; ERBB2-altered subpopulation highlighted as a candidate for HER2-directed ADC therapy including disitamab vedotin.

Sources

  • PMID:40256659 — Guercio et al. (2025). CALGB 90601 cfDNA biomarker study; ERBB2 cfDNA alterations in mUC associated with shorter OS; disitamab vedotin cited as a HER2-directed ADC option for ERBB2-altered disease.

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