IMpower210:A phase Ⅲ study of second-line atezolizumab vs. docetaxel in East Asian patients with non-small cell lung cancer  

作　　者：Yi-Long Wu Shun Lu Gongyan Chen Jianxing He Jifeng Feng Yiping Zhang Liyan Jiang Hongming Pan Jianhua Chang Jian Fang Amy Cai Lilian Bu Jane Shi Jinjing Xia 

机构地区：[1]Guangdong Lung Cancer Institute,Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer,Guangdong Provincial People's Hospital&Guangdong Academy of Medical Sciences,Southern Medical University,Guangzhou 510080,China [2]Shanghai Lung Cancer Center,Shanghai Chest Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200025,China [3]Department of Respiration,Harbin Cancer Hospital,Harbin Medical University,Harbin 150081,China [4]Department of Thoracic Oncology and Surgery,the First Affliated Hospital of Guangzhou Medical University,Guangzhou 510120,China [5]Department of Medical Oncology,Jiangsu Cancer Hospital,Nanjing 210009,China [6]Department of Medical Oncology,Zhejiang Cancer Hospital,Hangzhou 330022,China [7]Department of Pulmonary Medicine,Shanghai Chest Hospital,Shanghai Jiao Tong University,Shanghai 200030,China [8]Department of Medical Oncology,Sir Run Run Shaw Hospital,Zhejiang University School of Medicine,Hangzhou 310016,China [9]Department of Medical Oncology,Shenzhen Hospital,Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen 518116,China [10]Department of Thoracic Oncology,Beijing Cancer Hospital,Beijing 100142,China [11]Product Development,Shanghai Roche Pharmaceutical Ltd,Shanghai 201203,China

出　　处：《Chinese Journal of Cancer Research》2024年第2期103-113,共11页中国癌症研究（英文版）

基　　金：funded by F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd sponsored the IMpower210 study。

摘　　要：Objective: IMpower210(NCT02813785) explored the efficacy and safety of single-agent atezolizumab vs.docetaxel as second-line treatment for advanced non-small cell lung cancer(NSCLC) in East Asian patients.Methods: Key eligibility criteria for this phase Ⅲ, open-label, randomized study included age ≥18 years;histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system(7th edition);Eastern Cooperative Oncology Group performance status of 0 or 1;and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab(1,200 mg) or docetaxel(75 mg/m^(2)). The primary study endpoint was overall survival(OS) in the intention-to-treat(ITT) population with wild-type epidermal growth factor receptor expression(ITT EGFR-WT) and in the overall ITT population.Results: Median OS in the ITT EGFR-WT population(n=467) was 12.3 [95% confidence interval(95% CI),10.3-13.8] months in the atezolizumab arm(n=312) and 9.9(95% CI, 7.8-13.9) months in the docetaxel arm[n=155;stratified hazard ratio(HR), 0.82;95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5(95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1(95% CI, 8.4-14.2) months(n=377) with docetaxel treatment(n=188;stratified HR, 0.87;95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events(TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel arm.Conclusions: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGFR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade3/4 TRAEs.

关 键 词：Atezolizumab East Asia non-small cell lung cancer programmed death-ligand 1 inhibitors monoclonal antibody 

分 类 号：R734.2[医药卫生—肿瘤]