Efficacy and safety of KN026 and docetaxel for HER2‐positive breast cancer: a phase II clinical trial

作者：Jianli Ma, Jingxuan Wang, Ting Xu, Quchang Ouyang, Xiaojia Wang, Jingfen Wang, Lu Gan, Zhong Ouyang, Daren Lin, Tao Sun, Changping Shan, Herui Yao, Baochun Zhang, Zhengguang Li, Zhixiang Zhuang, Ying Lu, Hongwei Yang, Jian Huang, Xingwang Yang, Hongmei Sun, Qingyuan Zhang · 发表于：癌症：英文版 · 年份：2025 · DOI：10.1002/cac2.12662 · 被引用次数：9 · 研究领域：HER2/EGFR in Cancer Research、Monoclonal and Polyclonal Antibodies Research、Cancer Treatment and Pharmacology

BACKGROUND: The standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive recurrent/metastatic breast cancer currently includes pertuzumab plus trastuzumab and docetaxel. This study aimed to evaluate the effectiveness of KN026, an anti-HER2 bispecific antibody, plus docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer. METHODS: ) in 21-day cycles. Primary endpoints included the objective response rate (ORR) and duration of response (DOR). In addition, overall survival (OS), progression-free survival (PFS), clinical benefit rate (CBR) and safety profile were examined. RESULTS: A total of 57 patients were included. In the efficacy analysis set of 55 patients, the ORR was 76.4% (95% confidence interval [CI], 63.0%-86.8%), and the CBR was 85.5% (95% CI, 73.3%-93.5%). The median DOR was not reached (95% CI, 20.7 months-not reached). In the safety set of 57 patients, the median PFS was 27.7 months (95% CI, 18.0 months-not reached). The median OS was not reached, with OS rates at 12, 24 and 30 months of 93.0%, 84.1% and 78.5%, respectively. Grade ≥3 treatment-emergent adverse events (AEs) were detected in 36 (63.2%) patients. No deaths were attributed to KN026 or docetaxel. CONCLUSION: KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.