Alphamab Oncology reported that its HER2 bispecific antibody Anbenitamab Injection (KN026), in combination with Docetaxel for Injection (Albumin-bound) (HB1801), met the pre-specified primary endpoint in a Phase III trial evaluating neoadjuvant therapy for HER2-positive early or locally advanced breast cancer. The Phase III KN026-004 study showed that the Anbenitamab plus HB1801 regimen significantly improved total pathological complete response (tpCR) compared with the current standard of care regimen, TCbHP (trastuzumab plus pertuzumab and docetaxel ± carboplatin), with both statistical and clinical significance.
According to Alphamab, KN026-004 is the world’s first registrational, head-to-head Phase III study to demonstrate that a HER2 bispecific antibody is superior to the trastuzumab–pertuzumab monoclonal antibody combination, representing a historic milestone for bispecific antibodies in the neoadjuvant treatment of breast cancer. The positive data suggest a new neoadjuvant option for patients with HER2-positive early breast cancer that offers improved efficacy.
KN026-004 is a randomized, controlled, open-label, multicenter Phase III trial designed to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer. Patients are randomized 1:1 to receive either Anbenitamab plus HB1801 ± carboplatin or the control regimen of trastuzumab plus pertuzumab plus docetaxel ± carboplatin. The primary endpoint is tpCR, assessed by a blinded independent review committee, with detailed results to be presented at an upcoming international academic conference.
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