Zhitong Financial App News, Corning Jerry Pharmaceutical-B (09966) issued an announcement. Significant results of anituzumab (trade name: Enitumab®, R&D code: KN026) for first-line treatment of HER2+ BC and the updated OS analysis for second-line treatment of HER2+ GC/GEJ were presented in the form of an LBA oral report at the 2026 ESMO conference.
KN026-003/Healer is a randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy and safety of antizumab in combination with docetaxel (albumin binding) (HB1801) compared with trastuzumab plus pertuzumab and docetaxel (THP protocol) in first-line treatment of HER2+ recurrent or metastatic BC. The main end point was PFS assessed by BIRC. Patients with advanced HER2+ BC (no previous chemotherapy or HER2 targeted therapy in advanced stages) were randomly enrolled in a 1:1 ratio and treated with anituzumab plus HB1801 (antizumab group) or THP regimen (THP group), respectively. The study was assessed by an independent data monitoring committee in June 2026 and successfully reached the main end point. Currently, the program's new drug marketing application has been accepted by the NMPA and included in the priority review and approval process. The following results were published at the 2026 ESMO conference and simultaneously published in the “New England Journal of Medicine”.
KN026-001/KC-WISE is a randomized, double-blind, controlled, multicenter phase III clinical study to evaluate the efficacy and safety of anituzumab in combination with chemotherapy in patients with HER2+ GC/GEJ who have failed at least previous first-line treatment. Enrolled HER2+ GC/GEJ patients (disease progression after receiving trastuzumab-based treatment) were randomly treated with anituzumab combined chemotherapy (treatment group) or placebo combination chemotherapy (control group). At the 2025 ESMO conference, the KC-WISE study announced the results of the first mid-term analysis. Compared with placebo combined chemotherapy, anituzumab combined chemotherapy achieved clinically significant and statistically significant benefits in terms of PFS and OS, and had good controllable safety characteristics. For details, please refer to our announcement dated October 17, 2025. The plan was approved for listing in May 2026 through the NMPA priority review and approval process. The ESMO conference updated the OS mid-term analysis results set by the KC-WISE study.