^{Zhitong Finance App News, Shiyao Group (01093) announced that the midterm analysis results of the phase III clinical study (study number: HEALER) of anitumab injection (trade name: Enitum®) co-injectable docetaxel (albumin binding) (HB1801) for first-line treatment of human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer (study number: HEALER) on October 24, 2026 at the European Society of Oncology Medicine} The latest breaking abstract (LBA) was selected at the (ESMO) annual meeting and presented in the form of a selected oral report. At the same time, the study was simultaneously published in the “New England Journal of Medicine” (NEJM) in the form of an original paper, making it the first result published in NEJM in the clinical field of breast cancer in mainland China.

For a long time, trastuzumab combined with pertuzumab and yew (THP regimen) was the first-line standard treatment for advanced HER2-positive breast cancer. However, about half of patients progressed within 2 years, and clinically, there is an urgent need for better treatment options.

The HEALER study is a randomized, open-label phase III clinical study initiated by the group and led by Academician Xu Binghe at 76 centers in China. It aims to compare the efficacy and safety of antizumab combined with HB1801 and standard THP regimens in first-line treatment of advanced HER2-positive breast cancer. A total of 885 advanced HER2-positive breast cancer patients without advanced chemotherapy or anti-HER2 targeted therapy were randomly assigned 1:1 to the trial group (antitumab combined with HB1801 group) or control group (THP group). The primary endpoint was progression-free survival (PFS) as assessed by the Independent Blind Assessment Committee (BIRC) based on the Solid Tumor Efficacy Evaluation Criteria (RECIST 1.1).

The results of the HEALER study confirmed that the anituzumab combined with HB1801 regimen significantly improved first-line PFS in advanced HER2-positive breast cancer compared to the existing standard THP regimen, and the overall safety was controllable. The study provides high-quality evidence-based medical evidence for this novel combination therapy and is expected to be a new first-line treatment option for advanced HER2-positive breast cancer.