CSPC Pharmaceutical Group Limited (CSPC Pharma) released interim data from the HEALER Phase III study evaluating first-line treatment with Anbenitamab Injection (Ennituo) plus albumin-bound docetaxel (HB1801) in HER2-positive advanced breast cancer. The results were featured as a Late-breaking Abstract at the 2026 ESMO Congress on 24 October and published simultaneously in The New England Journal of Medicine—the first mainland-China breast-cancer study to appear in the journal.

Efficacy Overview • 885 treatment-naïve patients were randomised 1:1 to the experimental Anbenitamab + HB1801 arm or the standard trastuzumab-pertuzumab-taxane (THP) regimen. • Blinded Independent Review Committee analysis showed 24-month progression-free survival (PFS) rates of 58.5% for the experimental group versus 34.4% for THP, translating to a 54% reduction in risk of progression or death (HR 0.46; 95% CI 0.37–0.56; P = 6.37×10⁻¹⁵). • Objective response rate reached 87.6% vs 73.4% for THP. Median duration of response was not yet reached for the experimental arm; THP recorded 16.6 months. • PFS benefit was consistent across prespecified subgroups, including prior trastuzumab exposure and visceral metastases (both HR 0.47).

Safety Profile • Grade ≥3 adverse events occurred in 45.9% of patients on Anbenitamab + HB1801 and 34.4% on THP, mainly haematologic (neutropenia 13.1% vs 8.4%; leukopenia 9.7% vs 5.5%). • Treatment discontinuations due to adverse events were low: 5.2% vs 3.4%. Grade ≥3 diarrhoea was limited to 2.3% and caused no discontinuations. • Cardiotoxicity remained comparable to established anti-HER2 therapies, with Grade ≥3 left-ventricular dysfunction at 0.5% and decreased ejection fraction at 1.8%; no new safety signals emerged.

Clinical Implications The data demonstrate that Anbenitamab plus HB1801 delivers significantly longer PFS and higher response rates than the current THP standard while maintaining manageable toxicity, positioning the regimen as a potential new first-line option for HER2-positive advanced breast cancer in China. CSPC Pharma holds sole marketing authorisation for Anbenitamab and independently sponsored the trial, drawing on its in-house development and commercialisation capabilities.