Ma Jianli, Wang Jingxuan, Xu Ting, Ouyang Quchang, Wang Xiaojia, Wang Jingfen, Gan Lu, Ouyang Zhong, Lin Daren, Sun Tao, Shan Changping, Yao Herui, Zhang Baochun, Li Zhengguang, Zhuang Zhixiang, Lu Ying, Yang Hongwei, Huang Jian, Yang Xingwang, Sun Hongmei, Zhang Qingyuan
Department of Radiotherapy, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Department of Medical Oncology, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Cancer Commun (Lond). 2025 Apr;45(4):476-485. doi: 10.1002/cac2.12662. Epub 2025 Jan 18.
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.
This open-label, single-arm, phase II study enrolled patients with HER2-positive recurrent/metastatic breast cancer in 19 centers across China from December 30, 2019 to May 27, 2021. Patients were administered KN026 (30 mg/kg) plus docetaxel (75 mg/m) 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.
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.
KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.
人表皮生长因子受体2（HER2）阳性复发/转移性乳腺癌的标准一线治疗目前包括帕妥珠单抗联合曲妥珠单抗及多西他赛。本研究旨在评估抗HER2双特异性抗体KN026联合多西他赛一线治疗HER2阳性复发/转移性乳腺癌的有效性。
本开放标签、单臂、II期研究于2019年12月30日至2021年5月27日在中国19个中心纳入HER2阳性复发/转移性乳腺癌患者。患者接受KN026（30mg/kg）联合多西他赛（75mg/m²）治疗，每21天为一个周期。主要终点包括客观缓解率（ORR）和缓解持续时间（DOR）。此外，还评估了总生存期（OS）、无进展生存期（PFS）、临床获益率（CBR）和安全性。
共纳入57例患者。在55例患者的疗效分析集中，ORR为76.4%（95%置信区间[CI]，63.0%-86.8%），CBR为85.5%（95%CI，73.3%-93.5%）。中位DOR未达到（95%CI，20.7个月-未达到）。在57例患者的安全性分析集中，中位PFS为27.7个月（95%CI，18.0个月-未达到）。中位OS未达到，12个月、24个月和30个月时的OS率分别为93.0%、84.1%和78.5%。36例（63.2%）患者发生≥3级治疗中出现的不良事件（AE）。未发现因KN026或多西他赛导致的死亡。
KN026联合多西他赛一线治疗HER2阳性复发/转移性乳腺癌显示出有前景的疗效和可控的安全性。
