An investigational combination therapy for a common form of advanced breast cancer has successfully met its primary goal in a late-stage clinical trial.
The trial evaluated the efficacy and safety of a treatment regimen combining CSPC PHARMA's (ASX: 01093) investigational drug HB1801 with the bispecific antibody KN026, developed in partnership with a subsidiary.
This Phase III study, named Healer (KN026-003), was designed to compare this new combination against the current standard first-line treatment for HER2-positive advanced breast cancer.
According to an assessment by an independent data monitoring committee, the KN026 plus HB1801 regimen significantly extended patients' progression-free survival compared to the standard therapy, meeting the study's primary endpoint with both statistical and clinical significance.
The safety profile of the combination was also reported to be favorable, and a positive trend in overall survival benefit was observed.
Breast cancer is the second most common malignancy among women in China, with the HER2-positive subtype accounting for 20% to 30% of cases. A significant portion of patients are diagnosed at an advanced stage or experience recurrence after initial treatment, highlighting a substantial unmet medical need.
While the current standard treatment has improved outcomes, approximately half of patients still see their disease progress within two years.
The KN026 antibody, named anituozumab, is a bispecific antibody targeting HER2. It received marketing approval in China in May 2024 for a specific type of gastric cancer and has also met its primary endpoint in a separate Phase III study for neoadjuvant treatment of HER2-positive breast cancer.
Furthermore, anituozumab has been granted orphan drug designation by the U.S. FDA for gastric cancer and breakthrough therapy designation by Chinese regulators.
The other component, HB1801, is a novel albumin-bound formulation of docetaxel developed by CSPC. This formulation is designed to improve safety by eliminating certain solvents that can cause allergic reactions, potentially allowing for higher and faster dosing to enhance efficacy.
HB1801 is currently in Phase III clinical studies for several cancer indications, including breast and gastric cancer.
Detailed results from the Healer study are expected to be presented at an upcoming international scientific conference.
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