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

Yi-Long Wu ¹Shun Lu ²Gongyan Chen ³Jianxing He ⁴Jifeng Feng ⁵Yiping Zhang ⁶Liyan Jiang ⁷Hongming Pan ⁸Jianhua Chang ⁹Jian Fang ¹⁰Amy Cai ¹¹Lilian Bu ¹¹Jane Shi ¹¹Jinjing Xia¹¹

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作者信息

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 Affiliated 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
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Abstract

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/m2).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 grade 3/4 TRAEs.

Key words

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

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基金项目

F.Hoffmann-La Roche Ltd()

出版年

2024

中国癌症研究(英文版)

中国抗癌协会北京市肿瘤研究所

中国癌症研究(英文版)

CSTPCDCSCD

影响因子：1.592

ISSN：1000-9604

参考文献量24

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