Revolutionary Phase 3 Trial Results for Disitamab Vedotin in Urothelial Carcinoma: A New Era of Treatment
Transformative Phase 3 Clinical Trial Results
On May 12, 2025, RemeGen Co., Ltd., a pioneering biopharmaceutical company, declared significant achievements in their Phase 3 clinical trial of Disitamab Vedotin (DV), an innovative antibody-drug conjugate (ADC) designed to treat HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). This trial, labeled RC48-C016, evaluated the efficacy of DV in combination with the PD-1 inhibitor toripalimab, marking a potential shift in treatment paradigms for this challenging cancer.
Key Findings and Impact
The trial ultimately met its two primary endpoints: progression-free survival (PFS) and overall survival (OS). Encouraging results from an independent interim analysis revealed statistically meaningful differences in patient outcomes observed in the DV + toripalimab combination, compared to traditional chemotherapy regimens. These findings are particularly noteworthy given the diverse patient demographics involved, including variations in HER2 expression levels and eligibility for cisplatin treatment.
Professor Guo Jun from Peking University Cancer Hospital, the principal investigator, expressed his enthusiasm regarding the results.
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