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SYS6010，一种靶向表皮生长因子受体的抗体药物偶联物治疗晚期非小细胞肺癌：一项1期试验

SYS6010, epidermal growth factor receptor-targeting antibody-drug conjugate for advanced non-small cell lung cancer: A phase 1 trial.

期刊
Cancer Cell
PMID
42594871
原文
PubMed ↗
发布日期

作者

  • Zi-Ming Li — Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai 200030, P.R. China.
  • Zhen Zhou — Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai 200030, P.R. China.
  • Zhi-Yong He — Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou 350014, P.R. China.
  • Liang Han — Department of Oncology, Xuzhou Center Hospital, Xuzhou 221000, P.R. China.
  • Jian Fang — Department of Thoracic Oncology II, Beijing Cancer Hospital, Beijing 100142, P.R. China.
  • Hong-Mei Sun — Department of Medical Oncology, Jiamusi Tumor Hospital, Jiamusi 154000 P.R. China.
  • Hai-Feng Liu — Department of Critical Care Medicine, Jilin Cancer Hospital, Changchun 130000 P.R. China.
  • Ming-Xia Wang — Clinical Pharmacology and Medical Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, P.R. China.
  • Yi-Bing Liu — Department of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, P.R. China.
  • Xiu-Juan Qu — Department of Medical Oncology, The First Affiliated Hospital of China Medical University, Shenyang 110000, P.R. China.
  • Yu Yao — Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, P.R. China.
  • Yi Gong — Phase I Ward, Chongqing University Cancer Hospital, Chongqing 400030, P.R. China.
  • Yan Yu — Respiratory Medicine Ward 3, Cancer Hospital Affiliated to Harbin Medical University, Harbin 150000, P.R. China.
  • Hua-Qiu Shi — Department of Oncology, First Affiliated Hospital of Gannan Medical University, Ganzhou 341001, P.R. China.
  • Yan Wang — Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R. China.
  • Chun-Xia Su — Continuity of Care Unit, Shanghai Pulmonary Hospital, Shanghai 200433, P.R. China.
  • Kun-Yu Yang — Department of Oro-maxillofacial Head and Neck Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430048, P.R. China.
  • Yan-Hong Shang — Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding 071000, P.R. China.
  • Jian Ruan — Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P.R. China.
  • Xiang-Lin Yuan — Department of Medical Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, P.R. China.
  • Ming-Jun Zhang — Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, P.R. China.
  • Hui Luo — Department of Thoracic Tumor Radiotherapy, Jiangxi Cancer Hospital, Nanchang 330029 P.R. China.
  • Jiu-Wei Cui — Department of Oncology, The First Hospital of Jilin University, Changchun 130021, P.R. China.
  • Xiao-Yan Lin — Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou 350001, P.R. China.
  • Meng-Xia Li — Department of Oncology, Army Medical Center with Distinctive Features, Chongqing, 400010, P.R. China.
  • Hai-Zhou Lou — Department of Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310000, P.R. China.
  • Run-Xiang Yang — Department of Internal Medicine No.2, Yunnan Cancer Hospital, Kunming 650106, P.R. China.
  • Hao Wu — Department of Oncology, The First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, P.R. China.
  • Xi-Cheng Wang — Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, P.R. China.
  • Mo Dan — Preclinical Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Li-Qiong Zhang — Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Yang-Zhi Su — Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Xue-Chao Wan — Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Kai Zou — Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Ying-Ying Yang — Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Shun Lu — Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai 200030, P.R. China. Electronic address: shunlu@sjtu.edu.cn.

作者单位

  • Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai 200030, P.R. China.
  • Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou 350014, P.R. China.
  • Department of Oncology, Xuzhou Center Hospital, Xuzhou 221000, P.R. China.
  • Department of Thoracic Oncology II, Beijing Cancer Hospital, Beijing 100142, P.R. China.
  • Department of Medical Oncology, Jiamusi Tumor Hospital, Jiamusi 154000 P.R. China.
  • Department of Critical Care Medicine, Jilin Cancer Hospital, Changchun 130000 P.R. China.
  • Clinical Pharmacology and Medical Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, P.R. China.
  • Department of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, P.R. China.
  • Department of Medical Oncology, The First Affiliated Hospital of China Medical University, Shenyang 110000, P.R. China.
  • Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, P.R. China.
  • Phase I Ward, Chongqing University Cancer Hospital, Chongqing 400030, P.R. China.
  • Respiratory Medicine Ward 3, Cancer Hospital Affiliated to Harbin Medical University, Harbin 150000, P.R. China.
  • Department of Oncology, First Affiliated Hospital of Gannan Medical University, Ganzhou 341001, P.R. China.
  • Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R. China.
  • Continuity of Care Unit, Shanghai Pulmonary Hospital, Shanghai 200433, P.R. China.
  • Department of Oro-maxillofacial Head and Neck Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430048, P.R. China.
  • Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding 071000, P.R. China.
  • Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P.R. China.
  • Department of Medical Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, P.R. China.
  • Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, P.R. China.
  • Department of Thoracic Tumor Radiotherapy, Jiangxi Cancer Hospital, Nanchang 330029 P.R. China.
  • Department of Oncology, The First Hospital of Jilin University, Changchun 130021, P.R. China.
  • Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou 350001, P.R. China.
  • Department of Oncology, Army Medical Center with Distinctive Features, Chongqing, 400010, P.R. China.
  • Department of Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310000, P.R. China.
  • Department of Internal Medicine No.2, Yunnan Cancer Hospital, Kunming 650106, P.R. China.
  • Department of Oncology, The First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, P.R. China.
  • Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, P.R. China.
  • Preclinical Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Clinical Development Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang 050035, P.R. China.
  • Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai 200030, P.R. China. Electronic address: shunlu@sjtu.edu.cn.

摘要

中文

SYS6010是一种靶向表皮生长因子受体（EGFR）的抗体药物偶联物。我们报告了SYS6010在非小细胞肺癌（NSCLC）患者中的1期试验（ChiCTR2300072141）结果。共治疗了236名患者。在6.4 mg/kg剂量下发生1例剂量限制性毒性；因此，选择4.2、4.5和4.8 mg/kg进行队列扩展。治疗相关不良事件（TRAEs；任意/≥3级）发生率为99.6%/57.2%。常见的≥3级TRAEs包括中性粒细胞减少症（30.9%）、白细胞减少症（25.0%）和血小板减少症（17.4%）。在经EGFR酪氨酸激酶抑制剂（TKIs）和铂类化疗治疗的EGFR突变NSCLC中，客观缓解率为34.7%；在经EGFR TKIs治疗的EGFR突变NSCLC中为45.7%；在EGFR野生型鳞状NSCLC中为20.0%；在EGFR野生型非鳞状NSCLC中为35.7%。在经EGFR TKIs和铂类化疗治疗的EGFR突变NSCLC中，中位无进展生存期和总生存期分别为7.6和19.4个月。总体而言，SYS6010在既往治疗的晚期NSCLC中显示出可控的安全性和令人鼓舞的抗肿瘤活性。

English

SYS6010 is an antibody-drug conjugate targeting epidermal growth factor receptor (EGFR). We report the results of a phase 1 trial (ChiCTR2300072141) of SYS6010 in patients with non-small cell lung cancer (NSCLC). A total of 236 patients were treated. One dose-limiting toxicity occurred at 6.4 mg/kg; therefore, 4.2, 4.5, and 4.8 mg/kg were selected for cohort expansion. Treatment-related adverse events (TRAEs; any/grade ≥ 3) occurred in 99.6%/57.2% of patients. Common grade ≥3 TRAEs included neutropenia (30.9%), leukopenia (25.0%), and thrombocytopenia (17.4%). Objective response rate was 34.7% in EGFR-mutant NSCLC treated with EGFR tyrosine kinase inhibitors (TKIs) and platinum chemotherapy, 45.7% in EGFR-mutant NSCLC treated with EGFR TKIs, 20.0% in EGFR wild-type squamous NSCLC, and 35.7% in EGFR wild-type non-squamous NSCLC. Median progression-free survival and overall survival were 7.6 and 19.4 months, respectively, in EGFR-mutant NSCLC treated with EGFR TKIs and platinum chemotherapy. Overall, SYS6010 shows a manageable safety profile and encouraging antitumor activity in previously treated, advanced NSCLC.

分类与指标

研究类型
临床研究
病种
肺癌
JCR 分区
Q1
影响因子
56.1
新锐分区
1区