ALPHAMAB-B(09966): The Phase III clinical study of KN026 as adjuvant therapy for HER2-positive breast cancer has reached its primary endpoint.

ALPHAMAB-B (09966) announced that the joint injection of docetaxel (albumin-bound) (HB1801) developed in collaboration with Shanghai Jintian Biosciences Co., Ltd., a subsidiary of CSPC PHARMA Limited (stock code: 1093), for neoadjuvant treatment of human epidermal growth factor receptor 2 ("HER2") positive breast cancer reached the primary endpoint of the pre-set overall pathological complete response rate (tpCR) in Phase III clinical study (study code: KN026-004), with statistically and clinically significant results. Breast cancer (BC) is the most common malignancy in Chinese women, with the HER2-positive subtype accounting for approximately 20% to 30%. In China, about 75% of BC patients are diagnosed at an early or localized stage. Surgery combined with neoadjuvant and/or adjuvant therapy is the cornerstone for achieving a cure for early or locally advanced BC. Studies have shown that patients achieving tpCR after neoadjuvant therapy have significantly improved event-free survival (EFS) and overall survival (OS), with greater benefit seen in HER2-positive BC. However, even with the standard neoadjuvant therapy regimen - trastuzumab combined with pertuzumab and chemotherapy (THP/TCbHP), only approximately half of HER2-positive early or locally advanced breast cancer patients achieve tpCR. Additionally, the goal of neoadjuvant therapy is not only to increase tpCR but also to create conditions for early surgery. Therefore, there is still a need to explore more optimal and earlier neoadjuvant therapy regimens in clinical practice. Neo-Healer (KN026-004) is a randomized, controlled, open-label, multicenter, Phase III clinical trial planning to enroll approximately 520 early or locally advanced HER2-positive BC patients, with a 1:1 random allocation. The study aims to compare the efficacy and safety of KN026 combined with HB1801 carboplatin versus trastuzumab combined with pertuzumab and docetaxel carboplatin in neoadjuvant treatment of early and locally advanced HER2-positive BC. The primary endpoint of the study is tpCR assessed by the blinded independent review committee (BIRC). The study results show that compared to the current standard treatment, KN026 combined with HB1801 carboplatin significantly improves patients' tpCR. Detailed data from the study will be presented at an upcoming international academic conference.