By Fineline Cube 
China-based biopharma RemeGen Ltd (HKG: 9995) announced that the National Medical Products Administration (NMPA) has approved a new indication for its antibody drug conjugate (ADC) disitamab vedotin (RC48). The drug is now approved for the treatment of patients with HER2-positive advanced breast cancer with liver metastasis.
Clinical Trial Results
The approval is supported by results from the Phase III RC48-C006 study. The trial demonstrated that disitamab vedotin significantly prolonged progression-free survival (PFS) compared to lapatinib combined with capecitabine, reducing the risk of disease progression or death by 44% (median PFS: 9.9 months vs. 4.9 months, HR=0.56, P=0.0143). While overall survival (OS) data is not yet mature, disitamab vedotin has shown a stronger trend of benefit, with a median OS of non-assessable versus 25.9 months (HR=0.56, 95% CI: 0.25-1.29). The safety profile of disitamab vedotin was favorable, with no new safety signals observed.
Drug Background
Disitamab vedotin is the first domestically developed ADC in China. It received conditional market approval in June 2021 for the third-line treatment of HER2-positive gastric cancer (GC). On December 31, 2021, the NMPA granted a second approval for the drug to treat urothelial cancer (UC).-Fineline Info & Tech