CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that the Phase III trial (KN026-003) evaluating Anbenitamab (KN026) combined with its in-house Docetaxel for Injection (Albumin-bound, HB1801) as a first-line therapy for HER2-positive advanced breast cancer has met its prespecified primary endpoint of progression-free survival (PFS). An Independent Data Monitoring Committee confirmed the regimen delivered a statistically significant and clinically meaningful PFS improvement versus the current standard THP protocol (trastuzumab + pertuzumab + docetaxel). Safety results were reported as favourable, and an overall survival benefit trend was observed. Detailed efficacy and safety data will be presented at an upcoming international conference.
The open-label, randomised, multicentre study targets roughly 880 patients, equally allocated to receive either the KN026 + HB1801 combination or the THP regimen. The primary endpoint is PFS assessed by a Blinded Independent Review Committee.
Market context underscores the therapy’s relevance: HER2-positive disease accounts for 20%–30% of breast-cancer cases in China, where about 20% of patients present with advanced disease at diagnosis and roughly 10% of early-stage HER2-positive cases relapse within three years. Despite THP extending PFS, nearly half of patients progress within two years, highlighting the unmet need addressed by CSPC Pharma’s investigational regimen.
Anbenitamab, a HER2 bispecific antibody, secured Chinese marketing approval in May 2026 for second-line HER2-positive gastric or gastroesophageal junction adenocarcinoma therapy and holds U.S. FDA Orphan Drug Designation for HER2-expressing gastric cancer. HB1801, a polysorbate- and ethanol-free albumin-bound docetaxel formulation, is in Phase III trials for both breast and gastric cancer indications, offering potential safety and dosing advantages.
CSPC Pharma stated that an NDA for neoadjuvant use of Anbenitamab in HER2-positive breast cancer is forthcoming, while additional studies in adjuvant breast cancer and first-line gastric cancer are in progress.
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