CSPC PHARMA (01093): Anetumab ravtansine in combination with doxorubicin (albumin-bound) as neoadjuvant therapy achieves primary endpoint in phase III study for HER2+ breast cancer.

CSPC PHARMA (01093) announced that the company's subsidiary, Shanghai Jinmant Bio-technology Co., Ltd., in collaboration with Jiangsu ConineJer Biopharmaceutical Co., Ltd., has achieved significant statistical and clinical significance in the phase III clinical study (research protocol number: KN026-004) of the monoclonal antibody injection (KN026) developed for HER2 positive early or locally advanced breast cancer neoadjuvant therapy, with the endpoint of achieving the predefined overall pathological complete response rate (tpCR). Breast cancer is the second most common malignant tumor in Chinese women, with HER2-positive subtype accounting for about 20% to 30% of cases. In China, approximately 75% of breast cancer patients are diagnosed in the early or locally advanced stages. Surgery combined with neoadjuvant and/or adjuvant therapy is the key to curing early or locally advanced breast cancer. Studies have shown that patients who achieve tpCR after neoadjuvant therapy have significantly improved event-free survival (EFS) and overall survival (OS), especially in HER2-positive breast cancer. Despite this, only about half of HER2-positive early or locally advanced breast cancer patients achieve tpCR after receiving standard neoadjuvant therapy with trastuzumab combined with pertuzumab and chemotherapy (THP/TCbHP). In addition to increasing tpCR, neoadjuvant therapy also aims to facilitate earlier surgical treatment. Therefore, there is still a need to explore better neoadjuvant therapy regimens that can be implemented earlier in clinical practice. Neo-Healer (KN026-004) is a randomized, controlled, open-label, multicenter, phase III clinical study that plans to include approximately 520 HER2-positive early or locally advanced breast cancer patients, with a 1:1 randomization to compare the efficacy and safety of KN026 combined with HB1801 carboplatin vs. trastuzumab combined with pertuzumab and docetaxel carboplatin for neoadjuvant therapy of early and locally advanced HER2-positive breast cancer. The primary endpoint of the study is tpCR assessed by the blinded independent review committee (BIRC). The study results show that, compared to the existing standard treatment, KN026 combined with HB1801 carboplatin significantly improves patients' tpCR. The detailed data of this study will be presented at an upcoming international academic conference.