Phase 2 data from the RC48G001 study show the HER2‑targeted antibody‑drug conjugate disitamab vedotin (DV) produced confirmed overall response rates above 50% in previously treated metastatic urothelial carcinoma. Investigators reported a 54.9% confirmed response in the HER2‑positive cohort and 52.6% in the HER2‑low group, with median progression‑free survival of about 5.7 months in both cohorts. Results were presented at the ASCO Genitourinary Cancers Symposium. DV uses a HER2‑binding antibody linked to the microtubule inhibitor MMAE; its activity across HER2 expression levels mirrors trends seen with other ADCs attempting to broaden the responder population. Median overall survival estimates were reported near 20 months for the HER2‑positive group. Most prior clinical development for DV occurred in China, but global programs are underway as the bladder cancer community seeks non‑chemotherapy targeted options. The findings could expand HER2 as a therapeutic target in urothelial cancers and prompt comparative studies versus existing HER2 ADCs.
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