当前位置: X-MOL 学术N. Engl. J. Med. › 论文详情
Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
The New England Journal of Medicine ( IF 70.670 ) Pub Date : 2019-09-28 , DOI: 10.1056/nejmoa1910231
Matthew D Hellmann,Luis Paz-Ares,Reyes Bernabe Caro,Bogdan Zurawski,Sang-We Kim,Enric Carcereny Costa,Keunchil Park,Aurelia Alexandru,Lorena Lupinacci,Emmanuel de la Mora Jimenez,Hiroshi Sakai,Istvan Albert,Alain Vergnenegre,Solange Peters,Konstantinos Syrigos,Fabrice Barlesi,Martin Reck,Hossein Borghaei,Julie R Brahmer,Kenneth J O'Byrne,William J Geese,Prabhu Bhagavatheeswaran,Sridhar K Rabindran,Ravi S Kasinathan,Faith E Nathan,Suresh S Ramalingam

BACKGROUND In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC. METHODS In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more. RESULTS Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy. CONCLUSIONS First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level. No new safety concerns emerged with longer follow-up. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 227 ClinicalTrials.gov number, NCT02477826.).
更新日期:2019-11-21

 

全部期刊列表>>
向世界展示您的会议墙报和演示文稿
全球疫情及响应:BMC Medicine专题征稿
欢迎探索2019年最具下载量的化学论文
新版X-MOL期刊搜索和高级搜索功能介绍
化学材料学全球高引用
ACS材料视界
南方科技大学
x-mol收录
南方科技大学
自然科研论文编辑服务
西湖大学
中国科学院长春应化所于聪-4-8
武汉工程大学
课题组网站
X-MOL
深圳大学二维材料实验室张晗
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug