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Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study.

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收录情况： ◇ SCIE

作者：
Rui Wan[1] * ; Xiaorong Dong[2] * ; Qun Chen[3] ; Yan Yu[4] ; Shujun Yang[5] ; Xiaochun Zhang[6] ; Guojun Zhang[7] ; Yueyin Pan[8] ; Sanyuan Sun[9] ; Chengzhi Zhou[10] ; Wei Hong[11] ; Hui Zhao[12] ; Lei Yang[13] ; Linian Huang[14] ; Rong Wu[15] ; Aimin Zang[16] ; Rui Ma[17] ; Lin Wu[18] ; Dongqing Lv[19] ; Xiuhua Fu[20] ; Jianguo Han[21] ; Wenxin Li[22] ; Jianchun Duan[1] ; Kai Wang[23] ; Ou Jiang[24] ; Yinglan Chen[25] ; Zhongliang Guo[26] ; Hongjun Gao[27] ; Juyi Wen[28] ; Shubin Wang[29] ; Enfeng Zhao[30] ; Gaofeng Li[31] ; Lu Yue[32] ; Li Liang[33] ; Aiping Zeng[34] ; Xiaoshan Wang[35] ; Yuxi Zhu[36] ; Hongming Pan[37] ; Zhaoxia Dai[38] ; Weineng Feng[39] ; Guofang Zhao[40] ; Chuan Lin[41] ; Chong Li[42] ; Na Li[43] ; Yangyi Bao[44] ; Yinyin Li[45] ; Yanjun Su[46] ; Min Zhao[47] ; Haohui Fang[48] ; Yulong Zhu[49] ; Yu Zhang[50] ; Lieming Ding[51] ; Yang Wang[51] ; Xiaobin Yuan[51] ; Jie Wang[1,*1] ;
机构： [1]State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China [2]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [3]Medical Oncology, Fuzhou pulmonary Hospital of Fujian, Fuzhou, China [4]Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China [5]Department of Internal Medicine, Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China [6]Cancer Precision Medicine Center, The Affiliated Hospital of Qingdao University, Qingdao, China [7]Respiratory Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [8]Department of Oncology Chemotherapy, the First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, China [9]Oncology, Xuzhou Central Hospital, Xuzhou, China [10]Pulonary and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China [11]Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China [12]Respiratory, The Second Hospital of Anhui Medical University, Hefei, China [13]Department of Respiratory Oncology, Gansu Provincial Cancer Hospital, Lanzhou, China [14]Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China [15]Department of Internal Oncology II, Shengjing Hospital of China Medical University, Liaoning, China [16]Internal Medicine-Oncology, Affiliated Hospital of Hebei, Baoding, China [17]Medical Oncology Department of Thoracic Cancer (II), Liaoning Cancer Hospital & Institute, Shenyang, China [18]Thoracic Medicine Department II, Hunan Cancer Hospital, Changsha, China [19]Respiratory, Taizhou Hospital of Zhejiang Province, Taizhou, China [20]Department of Respiratory and Critical Care Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China [21]Oncology, Chifeng Municipal Hospital, Chifeng, China [22]Oncology, Inner Mongolia People’s Hospital, Hohhot, China [23]Respiratory, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China [24]Department of Oncology, The Second People’s Hospital of Neijiang, Neijiang, China [25]Medical Oncology, Jiangxi Province Cancer Hospital, Nanchang, China [26]Department of Respiratory Medicine, Shanghai East Hospital, Shanghai, China [27]Department of pulmonary oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China [28]Department of Radiation Oncology, The Sixth Medical Center of PLA General Hospital, Beijing, China [29]Medical Oncology, Peking University Shenzhen Hospital, Shenzhen, China [30]Three and Four Departments of Radiotherapy and Chemotherapy, Cangzhou Hospital of Integrated Traditional Chinese and Western of Hebei Province, Cangzhou, China [31]Thoracic surgery, Yunnan Cancer Hospital, Kunming, China [32]Oncology, Qingdao Municipal Hospital, Qingdao, China [33]Oncology, Peking University Third Hospital, Beijing, China [34]Department of Chemotherapy, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China [35]Oncology, Sichuan Provincial People’s Hospital, Chengdu, China [36]Department of Oncology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China [37]Oncology Department, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China [38]Department of Thoracic Medical Oncology II, The Second Hospital of Dalian Medical University, Dalian, China [39]Head and Neck/Thoracic Medical Oncology, The First People's Hospital of Foshan, Foshan, China [40]Department of Cardiothoracic Surgery, Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No.2 Hospital), Ningbo, China [41]Oncology, Yibin Second People's Hospital, Yibin, China [42]Department of Respiratory Medicine, The First People’s Hospital of Changzhou, Changzhou, China [43]Department of Oncology, Suining Central Hospital, Suining, China [44]Department of Oncology, The First People's Hospital of Hefei, Hefei, China [45]First Department of Oncology, Shenyang Chest Hospital, Shenyang, China [46]Department of Pulmonary Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China [47]Oncology, Hebei Chest Hospital, Shijiazhuang, China [48]Respiratory, Anhui Chest Hospital, Hefei, China [49]Department of Respiratory, Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region, Urumqi, China [50]Respiratory, Nanjing Chest Hospital, Nanjing, China [51]Betta pharmaceuticals Co., Ltd., Hangzhou, China
出处：
DOI： 10.1016/j.eclinm.2021.101187
ISSN：

关键词： MIL60 biosimilar bevacizumab equivalence non-squamous NSCLC

摘要：
We compared the efficacy, safety, and immunogenicity of MIL60 with reference bevacizumab as first-line treatment in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) in this phase 3, randomized, double-blind study.Patients with untreated advanced or recurrent NSCLC were randomized (1:1 ratio) to receive either MIL60 or bevacizumab in combination with paclitaxel/carboplatin. Patients with non-progressive disease continued maintenance single-agent MIL60 until disease progression, or intolerable toxicity. The primary endpoint was the 12-week objective response rates (ORR12) by independent review committee (IRC) using RECIST 1.1. Bioequivalence was established if the ORR ratio located between 0.75 and 1/0.75. The trial was registered with clinicaltrials.gov (NCT03196986).Between Aug 23, 2017, and May 8, 2019, 517 patients were randomly assigned to MIL60 group (n=257) and bevacizumab group (n=260). In the full analysis set (FAS) population including all randomized and evaluable patients who received at least one dose of MIL60 or bevacizumab, the ORR12 in MIL60 group and bevacizumab group were 48.6% and 43.1%, respectively. The ORR ratio of these two groups were 1.14 (90% CI 0.97-1.33), which fell within the pre-specified equivalence boundaries (0.75-1/0.75). The median DOR was 5.7 months (95% CI 4.5-6.2) for MIL60 and 5.6 months (95% CI 4.3-6.4) for bevacizumab. No significant difference was noted in median PFS (7.2 vs. 8.1 months; HR 1.01, 95% CI 0.78-1.30, p=0.9606) and OS (19.3 vs. 16.3 months; HR 0.81, 95% CI 0.64-1.02, p=0.0755). Safety and tolerability profiles were similar between the two groups. No patient detected positive for Anti-drug antibody (ADA).The efficacy, safety and immunogenicity of MIL60 were similar with bevacizumab, providing an alternative treatment option for advanced or recurrent non-squamous NSCLC.This study was sponsored by Betta Pharmaceutical Co., Ltd.© 2021 The Authors.

基金：
This study was sponsored by Betta Pharmaceutical Co., Ltd., which assisted with data analysis, data interpretation, manuscript preparation and review.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2021]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
共同第一作者：
通讯作者：
通讯机构： [1]State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China [*1]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
推荐引用方式(GB/T 7714)：
Rui Wan,Xiaorong Dong,Qun Chen,et al.Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study.[J].ECLINICALMEDICINE.2021,42:doi:10.1016/j.eclinm.2021.101187.
APA：
Rui Wan,Xiaorong Dong,Qun Chen,Yan Yu,Shujun Yang...&Jie Wang.(2021).Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study..ECLINICALMEDICINE,42,
MLA：
Rui Wan,et al."Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study.".ECLINICALMEDICINE 42.(2021)

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