Alphamab Oncology (Alphamab) reported that its Phase III trial KN026-003 evaluating Anbenitamab (KN026) plus CSPC Group’s docetaxel (albumin-bound) HB1801 as first-line therapy for HER2-positive advanced breast cancer achieved the pre-specified primary endpoint of progression-free survival (PFS). The Independent Data Monitoring Committee confirmed both statistically significant and clinically meaningful PFS improvement versus the current standard THP regimen (trastuzumab + pertuzumab + docetaxel), with a favourable trend in overall survival.
The randomized, controlled, open-label, multi-centre study is enrolling approximately 880 patients, allocating them 1:1 to either the investigational KN026 + HB1801 arm or the THP control arm. Efficacy is assessed by a Blinded Independent Review Committee, with PFS as the primary endpoint. Detailed data are slated for presentation at an upcoming international conference.
Anbenitamab is an anti-HER2 bispecific antibody developed via Alphamab’s proprietary CRIB platform. It binds two non-overlapping HER2 epitopes, simultaneously blocking signalling, enhancing ADCC and CDC, and down-regulating HER2 receptors. The therapy is already approved in China (May 2026) for use with chemotherapy in adults with previously treated HER2-positive gastric or gastroesophageal junction cancers. Multiple registrational trials are under way, covering neoadjuvant, adjuvant and first-line settings in breast and gastric cancers.
HB1801, developed by CSPC Group, packages docetaxel in albumin nanoparticles, eliminating Tween-80 and ethanol, thereby removing the need for steroid premedication and allowing higher dosing.
In August 2021, Alphamab licensed Mainland China development and commercial rights for Anbenitamab in breast and gastric cancers to Shanghai JMT-Bio Technology, a CSPC subsidiary.
The latest Phase III success reinforces Alphamab’s strategy of leveraging its bispecific antibody and ADC platforms to expand oncology indications. Shareholders and potential investors are advised to exercise caution, as future approvals for additional indications remain subject to regulatory review.