Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)

查看全文 作　　者：Yuankai [1]Shi;Lin [2]Wu;Xinmin [3]Yu;Puyuan [1]Xing;Yan [1]Wang;Jianying [4]Zhou;Airong [5]Wang;Jianhua [6]Shi;Yi [7]Hu;Ziping [8]Wang;Guangyu [9]An;Yong [10]Fang;Sanyuan [11]Sun;Caicun [12]Zhou;Changli [13]Wang;Feng [14]Ye;Xingya [15]Li;Junye [16]Wang;Mengzhao [17]Wang;Yunpeng [18]Liu;Yanqiu [19]Zhao;Ying [20]Yuan;Jifeng [21]Feng;Zhendong [22]Chen;Jindong [23]Shi;Tao [24]Sun;Gang [25]Wu;Yongqian [26]Shu;Qisen [27]Guo;Yi [28]Zhang;Yong [29]Song;Shucai [30]Zhang;Yuan [31]Chen;Wei [32]Li;Hongrui [33]Niu;Wenwei [34]Hu;Lijun [35]Wang;Jianan [36]Huang;Yang [37]Zhang;Ying [38]Cheng;Zhengdong [39]Wu;Bo [40]Peng;Jiya [40]Sun;Christoph [40]Mancao;Yanqi [41]Wang;Luyao [41]Sun

机构地区：[1]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 Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,Beijing,P.R.China;[2]Department II of Thoracic Medicine,Hunan Cancer Hospital,Changsha,Hunan,P.R.China;[3]Department of Medical Oncology,Zhejiang Cancer Hospital,Hangzhou,Zhejiang,P.R.China;[4]Department of Respiratory Diseases,The First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou,Zhejiang,P.R.China;[5]The Third Department of Chemotherapy,Weihai Municipal Hospital,Weihai,Shandong,P.R.China;[6]Department of Medical Oncology,Linyi Cancer Hospital,Linyi,Shandong,P.R.China;[7]Oncology Department,General Hospital of Chinese People’s Liberation Army,Beijing,P.R.China;[8]Department of Chest Medicine,Beijing Cancer Hospital,Beijing,P.R.China;[9]Department of Oncology,Beijing Chao-Yang Hospital,Capital Medical University,Beijing,P.R.China;[10]Department of Medical Oncology,Sir Run Run Shaw Hospital,Zhejiang University,Hangzhou,Zhejiang,P.R.China;[11]Department of Medical Oncology,Xuzhou Central Hospital,Xuzhou Medical University,Xuzhou,Jiangsu,P.R.China;[12]Department of Medical Oncology,Shanghai Pulmonary Hospital,Tongji University,Shanghai,P.R.China;[13]Department of Lung Cancer,Tianjin Medical University Cancer Institute and Hospital,Tianjin,P.R.China;[14]Department of Medical Oncology,Cancer Hospital,The First Affiliated Hospital of Xiamen University,School of Medicine,Xiamen University,The Third Clinical Medical College,Fujian Medical University,Xiamen,Fujian,P.R.China;[15]Department of Medical Oncology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,P.R.China;[16]Department of Oncology,Affiliated Hospital of Jining Medical University,Jining,Shandong,P.R.China;[17]Department of Respiratory and Critical Care Medicine,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing,P.R.China;[18]Department of Medical Oncology,Key Laboratory of Anticancer Drugs and Biotherapy of Liaoning Province,The First Hospital of China Medical University,Shenyang,Liaoning,P.R.China;[19]Department of Internal Medicine,Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou,Henan,P.R.China;[20]Department of Medical Oncology,The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,Zhejiang,P.R.China;[21]Department of Medical Oncology,Jiangsu Cancer Hospital,Jiangsu Institute of Cancer Research,The Affiliated Cancer Hospital of Nanjing Medical University,Nanjing,Jiangsu,P.R.China;[22]Department of Oncology,The Second Hospital of Anhui Medical University,Hefei,Anhui,P.R.China;[23]Department of Respiratory Medicine,Shanghai Fifth’People’s Hospital,Fudan University,Shanghai,P.R.China;[24]Department of Medical Oncology,Cancer Hospital of China Medical University,Liaoning Cancer Hospital&Institute,Shenyang,Liaoning,P.R.China;[25]Cancer Center,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei,P.R.China;[26]Department of Oncology,The First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,P.R.China;[27]Department of Oncology,Shandong Cancer Hospital Affiliated to Shandong University,Shandong Academy of Medical Sciences,Shandong Cancer Hospital and Institute,Jinan,Shandong,P.R.China;[28]Department of Thoracic Surgery,Xuanwu Hospital,Capital Medical University,Beijing,P.R.China;[29]Department of Respiratory and Critical Care Medicine,The General Hospital of the Eastern Theater Command of PLA,Nanjing,Jiangsu,P.R.China;[30]Department of Oncology,Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor Research Institute,Beijing,P.R.China;[31]Department of Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei,P.R.China;[32]Cancer Center,The First Hospital of Jilin University,Changchun,Jilin,P.R.China;[33]Department of Oncology,The First Affiliated Hospital of Xinxiang Medical University,Xinxiang,Henan,P.R.China;[34]Department of Oncology,The First People’s Hospital of Changzhou,Changzhou,Jiangsu,P.R.China;[35]Department of Tumor Radiotherapy,The Second Affiliated Hospital of Xingtai Medical College,Xingtai,Hebei,P.R.China;[36]Department of Respiratory Medicine,The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,P.R.China;[37]Department of Oncology,The Second Hospital of Dalian Medical University,Dalian,Liaoning,P.R.China;[38]Department of Thoracic Oncology,Jilin Cancer Hospital,Changchun,Jilin,P.R.China;[39]Department of Oncology,Jiangsu Taizhou People’s Hospital,Taizhou,Jiangsu,P.R.China;[40]New Drug Biology and Translational Medicine,Innovent Biologics,Inc.,Suzhou,Jiangsu,P.R.China;[41]Medical Science and Strategy Oncology,Innovent Biologics,Inc.,Suzhou,Jiangsu,P.R.China

出　　处：《Cancer Communications》索引2022年第42卷第12期,共17页

基　　金：funded by Innovent biologics,Inc.;Eli Lilly and Company;partly supported by China National Major Project for New Drug Innovation(2017ZX09304015). 摘　　要：Background:Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer(sqNSCLC)after failure of first-line chemotherapy are limited.This study(ORIENT-3)aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.Methods:ORIENT-3 was an open-label,multicenter,randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy.Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m^(2) of docetaxel intravenously every 3 weeks,stratified by the Eastern Cooperative Oncology Group performance status.The primary endpoint was overall survival(OS)in the full analysis set(FAS).Secondary endpoints included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),duration of response(DoR)and safety.Results:Between August 25,2017,and November 7,2018,290 patients were randomized.For FAS,10 patients fromthe docetaxel armwere excluded.Themedian OS was 11.79(n=145;95%confidence interval[CI],10.28-15.57)months with sintilimab versus 8.25(n=135;95%CI,6.47-9.82)months with docetaxel(hazard ratio[HR]:0.74;95%CI,0.56-0.96;P=0.025).Sintilimab treatment significantly prolonged PFS(median 4.30 vs.2.79 months;HR:0.52;95%CI,0.39-0.68;P<0.001)and showed higher ORR(25.50%vs.2.20%,P<0.001)and DCR(65.50%vs.37.80%,P<0.001)than the docetaxel arm.The median DoRwas 12.45(95%CI,4.86-25.33)months in the sintilimab arm and 4.14(95%CI,1.41-7.23)months in the docetaxel arm(P=0.045).Treatment-related adverse events of grade≥3were reported in 26(18.1%)patients in the sintilimab arm and 47(36.2%)patients in the docetaxel arm.Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors,including OVOL2(HR:0.35;P<0.001)and CTCF(HR:3.50;P<0.001),for sintilimab treatment.Conclusions:Compared with docetaxel,sintilimab significantly improved the OS,PFS,and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC. 关键词：Non-small cell lung cancer Carcinoma squamous cell Sintilimab Immunotherapy Survival Randomized controlled trial

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Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)

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