CSPC PHARMA (01093) announced that anitolumab injection (KN026), co-developed by its subsidiary Shanghai GeneMedi Biotechnology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd., has met the pre-specified primary endpoint of total pathological complete response (tpCR) in a Phase III clinical study. The trial evaluated KN026 in combination with the group's self-developed docetaxel for injection (albumin-bound), HB1801, as a neoadjuvant treatment for HER2-positive early or locally advanced breast cancer. The results demonstrated significant statistical and clinical relevance.
Breast cancer is the second most common malignancy among women in China, with the HER2-positive subtype accounting for approximately 20% to 30% of cases. About 75% of breast cancer patients in China are diagnosed at an early or locally advanced stage. Surgery combined with neoadjuvant and/or adjuvant therapy is a core approach to achieving a cure in such cases. Research indicates that patients who achieve tpCR after neoadjuvant therapy experience significant improvements in both event-free survival (EFS) and overall survival (OS), particularly in HER2-positive breast cancer.
However, only about half of HER2-positive early or locally advanced breast cancer patients achieve tpCR after receiving the standard neoadjuvant regimen of trastuzumab plus pertuzumab and chemotherapy (THP/TCbHP). In addition to improving tpCR rates, neoadjuvant therapy also aims to enable earlier surgical intervention. Therefore, there remains a clinical need for more effective neoadjuvant regimens that allow for timely surgery.
The Neo-Healer (KN026-004) study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer. Participants were randomized 1:1 to compare the efficacy and safety of KN026 combined with HB1801, with or without carboplatin, against the standard regimen of trastuzumab plus pertuzumab and docetaxel, with or without carboplatin. The primary endpoint was tpCR as assessed by a blinded independent review committee (BIRC).
Results showed that KN026 combined with HB1801, with or without carboplatin, significantly improved tpCR rates compared to the current standard treatment. Detailed data from the study will be presented at an upcoming international academic conference.
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