Weekly Digest - January 2025

Weekly Digest - January 2025

27 Dec 2024: Alphamab Oncology announced anti-HER2 bispecific ADC JSKN003 received approval from CDE to initiate a Phase III clinical study for ovarian cancer

  • Alphamab Oncology’s anti-HER2 bispecific ADC JSKN003 has received approval from the NMPA’s Center for Drug Evaluation (CDE) to initiate a Phase III clinical trial (JSKN003-306) for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

  • JSKN003, an anti-HER2 bispecific ADC developed by Alphamab, has shown favorable safety, tolerability, and promising efficacy in advanced solid tumors, including PROC, in clinical studies conducted in Australia and China
  • Data from Phase I trials presented at the 2024 ESMO showed that JSKN003 monotherapy demonstrated promising efficacy in PROC patients, regardless of prior treatments or HER2 expression
  • The Phase III study (JSKN003-306) will be a randomized, open-label, multi-center trial comparing the efficacy and safety of JSKN003 against investigator-selected chemotherapy in patients with platinum-resistant recurrent ovarian, peritoneal, or fallopian tube cancer who have received 1-4 prior treatments

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