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 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

作者机构：Guangdong Lung Cancer InstituteGuangdong Provincial Key Laboratory of Translational Medicine in Lung CancerGuangdong Provincial People's Hospital&Guangdong Academy of Medical SciencesSouthern Medical UniversityGuangzhou 510080China Shanghai Lung Cancer CenterShanghai Chest HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200025China Department of RespirationHarbin Cancer HospitalHarbin Medical UniversityHarbin 150081China Department of Thoracic Oncology and Surgerythe First Affliated Hospital of Guangzhou Medical UniversityGuangzhou 510120China Department of Medical OncologyJiangsu Cancer HospitalNanjing 210009China Department of Medical OncologyZhejiang Cancer HospitalHangzhou 330022China Department of Pulmonary MedicineShanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Department of Medical OncologySir Run Run Shaw HospitalZhejiang University School of MedicineHangzhou 310016China Department of Medical OncologyShenzhen HospitalCancer Hospital of Chinese Academy of Medical SciencesShenzhen 518116China Department of Thoracic OncologyBeijing Cancer HospitalBeijing 100142China Product DevelopmentShanghai Roche Pharmaceutical LtdShanghai 201203China 

出 版 物：《Chinese Journal of Cancer Research》 (中国癌症研究（英文版）)

年 卷 期：2024年第36卷第2期

页      面：103-113页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

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

主　　题：Atezolizumab East Asia non-small cell lung cancer programmed death-ligand 1 inhibitors monoclonal antibody 

摘      要：Objective: IMpower210(NCT02813785) explored the efficacy and safety of single-agent atezolizumab *** as second-line treatment for advanced non-small cell lung cancer(NSCLC) in East Asian ***: 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 ***: 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 ***: 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.