CSPC PHARMA (01093): Phase III clinical study results of Anitumab combined with Docetaxel for Injection (Albumin-Bound) (HB1801) for first-line treatment of HER2-positive advanced breast cancer presented as a Proffered Oral Presentation at the 2026 ESMO Annual Meeting

CSPC PHARMA (01093) announced that the interim analysis results of the Phase III clinical study (Study No.: HEALER) of Anitumab Injection (trade name: Ennituo) combined with Docetaxel for Injection (Albumin-Bound) (HB1801), jointly developed by the Group and Jiangsu Alphamab Biopharmaceuticals Co., Ltd., for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer, were selected as a Late-breaking Abstract (LBA) at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting on October 24, 2026, and were presented as a Proffered Oral Presentation. At the same time, the study was simultaneously published as an original article in the New England Journal of Medicine (NEJM), making it the first achievement in the field of breast cancer clinical research in mainland China to be published in NEJM. For a long time, trastuzumab combined with pertuzumab and taxanes (THP regimen) has been the first-line standard treatment for HER2-positive advanced breast cancer. However, approximately half of patients experience disease progression within two years, and better treatment options are urgently needed in clinical practice. The HEALER study is a randomized, open-label Phase III clinical study initiated by the Group, led by Academician Xu Binghe, and conducted at 76 centers in China, aiming to compare the efficacy and safety of the Anitumab combined with HB1801 regimen versus the standard THP regimen in the first-line treatment of HER2-positive advanced breast cancer. The study enrolled a total of 885 patients with HER2-positive advanced breast cancer who had not received chemotherapy or anti-HER2 targeted therapy in the advanced setting, and they were randomly assigned 1:1 to the experimental group (Anitumab combined with HB1801 group) or the control group (THP group). The primary endpoint was progression-free survival (PFS) assessed by the Blinded Independent Review Committee (BIRC) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The results of the HEALER study confirmed that the Anitumab combined with HB1801 regimen significantly improved first-line PFS in HER2-positive advanced breast cancer compared with the existing standard THP regimen, with an overall manageable safety profile. The study provides high-quality evidence-based medical evidence for this novel combination therapy and is expected to become a new option for first-line treatment of HER2-positive advanced breast cancer.