RemeGen has reported Phase III RC48-C016 trial results showing disitamab vedotin + toripalimab achieved 31.5 month median overall survival (mOS) versus 16.9 months for chemotherapy in first-line human HER2-expressing locally advanced or metastatic urothelial carcinoma (Ia/mUC). The antibody-drug conjugate (ADC) and PD-1 inhibitor combination reduced death risk by 46% with 64% progression-free survival (PFS) improvement, demonstrating 13.1 month median PFS versus 6.5 months in the control group. Safety profile showed 55.1% grade three or higher adverse events versus 86.9% rate with chemotherapy, with manageable transaminase elevations and peripheral neuropathy.

The trial enrolled 484 patients across human HER2expression levels, showing consistent benefit regardless of cisplatin eligibility or tumour location. Disitamab vedotin's human HER2-targeting mechanism enables broad application in 80% of UC  patients beyond traditional high-expression criteria. RemeGen submitted a new drug application (NDA) in July 2025 following dual endpoint achievement, positioning the combination as a potential new standard of care with superior outcomes.

According to PharmCube's NextBiopharm® database, disitamab vedotin is the third most advanced HER2 ADC globally. Click here to request a free trial for NextBiopharm®.