Anti-HER2 bispecific ADC JSKN003 received approval to initiate a phase 3 clinical study for the treatment of HER2-positive breast cancer

CAR-T Digest - August 2020

Weekly Digest - February 2025

06 Feb 2025: Anti-HER2 bispecific ADC JSKN003 received approval to initiate a phase 3 clinical study for the treatment of HER2-positive breast cancer

Alphamab oncology and CSPC pharmaceutical received NMPA approval to initiate a Phase 3 study (JSKN003-301) for JSKN003 in HER2-positive advanced breast cancer
JSKN003-301 will compare JSKN003 with trastuzumab emtansine (T-DM1) in previously treated patients, following prior Phase 3 trials in HER2-low breast cancer and platinum-resistant ovarian cancer
Clinical studies in China and Australia have shown JSKN003’s favourable safety and efficacy, particularly in heavily pretreated HER2-expressing breast cancer and PROC patients
The Phase 3 study is a randomized, controlled, open-label trial with PFS as the primary endpoint, assessed by the blinded independent review committee (BIRC)