Alphamab Oncology Announces the Phase III Clinical Study of Anbenitamab (KN026) Combined with HB1801 as Neoadjuvant Treatment for Breast Cancer Has Met the Primary Endpoint

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[{"type":"text","content":"SUZHOU, China, April 1, 2026 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) today announced that HER2 bispecific antibody Anbenitamab Injection (KN026), independently developed by the Company, and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), in combination with Docetaxel for Injection (Albumin-bound) (HB1801), has met the pre-specified primary endpoint of total pathological complete response (tpCR) in a Phase III clinical study (KN026-004) for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer (BC). Compared with the current standard of care (trastuzumab plus pertuzumab and docetaxel±carboplatin, i.e., the TCbHP regimen), the Anbenitamab combination therapy significantly improved tpCR, with both statistical and clinical significance.","length":880,"tagName":"p"},{"type":"text","content":"KN026-004 is the world's first registrational study to demonstrate in a head-to-head Phase III trial that a HER2 bispecific antibody is superior to the combination of trastuzumab and pertuzumab (two monoclonal antibodies), marking a historic breakthrough for bispecific antibodies in the neoadjuvant treatment of breast cancer. Detailed data will be presented at an upcoming international academic conference. The positive results of KN026-004 offer a promising new neoadjuvant option for patients with HER2-positive early breast cancer – one that delivers better efficacy.","length":577,"tagName":"p"},{"type":"text","content":"Study Design","length":12,"tagName":"p"},{"type":"text","content":"KN026-004 is a randomized, controlled, open-label, multicenter Phase III study designed to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer, randomized 1:1 to the experimental arm (Anbenitamab + HB1801 ± carboplatin) or the control arm (trastuzumab + pertuzumab + docetaxel ± carboplatin). The primary endpoint is tpCR assessed by a blinded independent review committee (BIRC).","length":421,"tagName":"p"},{"type":"text","content":"Key Clinical Advantages","length":23,"tagName":"p"},{"type":"text","content":"Shorter Regimen: KN026-004 adopts a single-stage, continuous 6-cycle regimen (Anbenitamab + HB1801 ± carboplatin), allowing patients to undergo radical surgery approximately 6 wee...

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