ALPHAMAB-B (09966) announced that significant results from the Phase III clinical trial (Study Number: KN026-004) evaluating KN026 combined with HB1801 as a neoadjuvant treatment for HER2-positive breast cancer have been selected for presentation in the Late-Breaking Abstract (LBA) oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The study was developed in collaboration with JMT Bio, a subsidiary of CSPC Pharmaceutical Group (01093).

KN026-004 is a randomized, controlled, open-label, multicenter Phase III study led by Professor Zhi-Ming Shao from Fudan University Shanghai Cancer Center. The trial aims to evaluate the efficacy and safety of KN026 combined with HB1801, with or without carboplatin, compared to the standard regimen of trastuzumab plus pertuzumab and docetaxel, with or without carboplatin, as a neoadjuvant treatment for patients with HER2-positive early or locally advanced breast cancer.

Results demonstrated that the KN026 combination therapy significantly improved the total pathological complete response (tpCR) rate in patients compared to the current standard treatment (TCbHP). The findings represent the first time a head-to-head Phase III trial has shown that a HER2 bispecific antibody can outperform the dual monoclonal antibody combination of trastuzumab and pertuzumab, with a manageable safety profile. The KN026 combination therapy has the potential to become a new standard of care for neoadjuvant treatment in HER2-positive early and locally advanced breast cancer.