REMEGEN (688331.SH): The VDZ single-chain antibody first-line treatment for HER2-expressing urothelial carcinoma reached the primary endpoint of Phase III clinical study.

REMEGEN (688331.SH) announced that its independently developed antibody-drug conjugate (ADC) Vediruximab-doxorubicin (code: RC48, trade name: Aitis) Aitis, in combination with trastuzumab, compared to chemotherapy in the first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma in a phase III clinical study (RC48-C016), achieved the two main study endpoints of progression-free survival (PFS) and overall survival (OS). In the phase III clinical study (RC48-C016) of Vediruximab-doxorubicin in combination with trastuzumab compared to chemotherapy in the first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma, positive results were shown in the midterm analysis by the Independent Data Monitoring Committee (IDMC), meeting the two main study endpoints of PFS and OS with statistically significant differences and significant clinical benefits. In the main subgroup analysis, Vediruximab-doxorubicin in combination with trastuzumab significantly improved PFS and OS compared to chemotherapy, regardless of whether patients had received prior cisplatin treatment and regardless of HER2 expression status, with good safety and manageable adverse reactions. The company will submit a new drug application for this indication to the National Medical Products Administration's Center for Drug Evaluation (CDE) at an appropriate time.