CSPC Pharmaceutical Group (HKEX: 01093) announced on March 31 that anbenitamab (KN026), a HER2 bispecific antibody, met its pre-specified primary endpoint of total pathological complete response (tpCR) in a Phase III neoadjuvant trial for HER2-positive early or locally advanced breast cancer — a direct challenge to the pertuzumab-plus-trastuzumab standard that has gone largely unimproved for over a decade.
The Neo-Healer trial (KN026–004) is a randomized, controlled, open-label, multicenter Phase III study planned to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer, assigned 1:1 to experimental or control arms.
Anbenitamab combined with HB1801 (albumin-bound docetaxel) ± carboplatin significantly improved tpCR compared with trastuzumab plus pertuzumab and docetaxel ± carboplatin, assessed by a Blinded Independent Review Committee. No numerical tpCR rates, confidence intervals, or p-values were disclosed. CSPC said detailed data would be presented at an international conference. No trial-specific safety data were reported in the announcement.
Anbenitamab is a bispecific antibody that simultaneously targets two distinct epitopes on the HER2 receptor, designed to deliver dual-domain blockade through a single molecule rather than the two-antibody approach of the current standard regimen. HB1801 encapsulates docetaxel in human serum albumin, eliminating the polysorbate 80 and ethanol solvents used in conventional formulations, which removes the need for hypersensitivity premedication and permits higher-concentration, faster administration. The combination positions a mechanistically differentiated anti-HER2 agent against a chemotherapy backbone that itself carries a distinct safety profile relative to standard docetaxel. The approved standard — pertuzumab plus trastuzumab with taxane-based chemotherapy — achieves tpCR in roughly half of patients with early or locally advanced HER2-positive disease.