By Fineline Cube 
China-based RemeGen Ltd (HKG: 9995) announced that its Phase III clinical study for the antibody drug conjugate (ADC) disitamab vedotin (RC48) in combination with the PD-1 inhibitor toripalimab has achieved its two primary endpoints of progression-free survival (PFS) and overall survival (OS). The study compared the combination therapy to standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).
Clinical Study Results
Major subgroup analyses demonstrated that the combination of disitamab vedotin and toripalimab significantly improved PFS and OS compared to standard chemotherapy, regardless of cisplatin eligibility or HER2 expression levels. The regimen also exhibited a manageable safety profile with tolerable adverse reactions.
Regulatory Plans
RemeGen plans to file a Biologic License Application (BLA) for this indication with the Center of Drug Evaluation of the National Medical Products Administration (NMPA) in China.-Fineline Info & Tech