RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint.
The open, parallel-controlled, multi-center Phase III study aimed to evaluate the efficacy and safety of disitamab vedotin versus a combination of lapatinib and capecitabine for treating HER2 positive breast cancer. The final analysis revealed that disitamab vedotin significantly improved progression-free survival (PFS) compared to the lapatinib and capecitabine combination. The safety profile of disitamab vedotin was consistent with known risks, with no new safety signals identified.
Disitamab vedotin marked a significant milestone as the first domestically developed ADC in China, receiving conditional market approval in June 2021 for the treatment of HER2-positive gastric cancer (GC). The drug received a second approval from the National Medical Products Administration (NMPA) on December 31 for the treatment of urothelial cancer (UC). The NMPA also granted breakthrough therapy designation (BTD) to disitamab vedotin for HER2 positive advanced breast cancer with liver metastasis, with preparations underway for a market filing in China.- Flcube.com
