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Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study

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收录情况： ◇ 统计源期刊 ◇ 卓越：领军期刊

作者：
Liu Dan[1] * ; Gong Jifang[2] * ; Li Jian[2] * ; Qi Changsong[3] * ; Niu Zuoxing[4] * ; Liu Bo[4] ; Peng Zhi[2] ; Luo Suxia[5] ; Wang Xicheng[6] ; Wang Yakun[2] ; Zhao Rusen[7] ; Chen Lilin[8] ; Deng Ting[9] ; Li Zhen[10] ; Chen Lei[11] ; Fang Meimei[11] ; Yang Hongwei[12] ; Lu Linzhi[13] ; Zhang Yanming[14] ; Kang Fengling[15] ; Xu Ting[15] ; Zhang Xiaotian[2] ; Shen Lin[2] ;
机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Center, Peking University Cancer Hospital and Institute, Beijing, China [2]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China [3]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Early Drug Development Center, Peking University Cancer Hospital and Institute, Beijing, China [4]Department of Medical Oncology, Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital), Jinan, Shandong, China [5]Department of Internal Medicine, Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, China [6]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China [7]Department of Medical Oncology, Zibo Municipal Hospital, Zibo, Shandong, China [8]Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China [9]Department of GI Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China [10]Department of Internal Medicine Ward 5, Linyi Cancer Hospital, Linyi, Shandong, China [11]Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China [12]Department of Breast and Thyroid Surgery, Suining Central Hospital, Suining, Sichuan, China [13]Gastroenterology Department, Gansu Wuwei Tumour Hospital, Wuwei, Gansu, China [14]Oncology Inpatient Area 2/3, Linfen Central Hospital, Linfen, Shanxi, China [15]Jiangsu Alphamab Biopharmaceuticals Co., Ltd., Suzhou, Jiang Su, China
出处：
DOI： 10.1038/s41392-025-02195-x
ISSN：

摘要：
To evaluate the efficacy and safety of KN026, a novel bispecific HER2 (ECD2 and ECD4) antibody, plus KN046, a PD-L1, and CTLA4 bispecific antibody, in patients with advanced HER2-positive solid tumors. We conducted two sequentially designed phase Ib and II studies with similar target populations and evaluation schedules. The primary endpoints included safety, maximum tolerated dose (MTD), the recommended phase II dose (RP2D) for the phase Ib study, and the objective response rate (ORR) and duration of response (DoR) for the phase II study. Hereby, we solely report the results from 113 nonbreast cancer patients. In phase Ib, MTD was not reached. Dose 3 was confirmed to be acceptable for the phase II study. An objective response has been exclusively observed in HER2-positive patients. Any grade treatment-related adverse events (TRAEs) were reported in 108 (95.6%) patients. The most common TRAEs were infusion reactions (38.9%), anemia (37.2%), elevated AST (31.0%), and diarrhea (30.1%). Among the 108 patients evaluated for efficacy, the overall ORR was 55.6% (95%CI, 45.7%, 65.1%). In the HER2-positive GC subgroup, 38 patients received this regimen as the 1st-line treatment and 30 patients achieved an objective response, with an ORR of 78.9% (95%CI, 62.7%, 90.4%). Among 27 pretreated patients, the ORR was 44.4% (95%CI, 25.5%, 64.7%). In the other HER2-positive solid tumor subgroup (n = 34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.© 2025. The Author(s).

基金：
Jiangsu Alphamab Biopharmaceuticals Co., Ltd. This work was also supported by the National Natural Science Foundation of China (91959205 to L.S.) and the Natural Science Foundation of Beijing Municipality (Z200015 to X.T.Z)
语种：
外文
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出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学
第一作者：
第一作者机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Center, Peking University Cancer Hospital and Institute, Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Liu Dan,Gong Jifang,Li Jian,et al.Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study[J].Signal Transduction And Targeted Therapy.2025,10(1):104.doi:10.1038/s41392-025-02195-x.
APA：
Liu Dan,Gong Jifang,Li Jian,Qi Changsong,Niu Zuoxing...&Shen Lin.(2025).Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study.Signal Transduction And Targeted Therapy,10,(1)
MLA：
Liu Dan,et al."Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study".Signal Transduction And Targeted Therapy 10..1(2025):104

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