干旱区生态环境知识资源中心(Arid): Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC in the Phase 3 ORIENT-11 Study

Arid

DOI	10.1016/j.jtho.2021.07.015
	Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC in the Phase 3 ORIENT-11 Study
	Yang, Yunpeng; Sun, Jiya; Wang, Zhehai; Fang, Jian; Yu, Qitao; Han, Baohui; Cang, Shundong; Chen, Gongyan; Mei, Xiaodong; Yang, Zhixiong; Ma, Rui; Bi, Minghong; Ren, Xiubao; Zhou, Jianying; Li, Baolan; Song, Yong; Feng, Jifeng; Li, Juan; He, Zhiyong; Zhou, Rui; Li, Weimin; Lu, You; Zhou, Hui; Wang, Shuyan; Sun, Luyao; Puig, Oscar; Mancao, Christoph; Peng, Bo; Fang, Wenfeng; Xu, Wei; Zhang, Li
通讯作者	Zhang, L (corresponding author)，Sun Yat Sen Univ, Canc Ctr, Collaborat Innovat Ctr Canc Med, Med Oncol Dept,State Key Lab Oncol South China, 651 Dongfeng East Rd, Guangzhou 510060, Guangdong, Peoples R China.
会议名称	Virtual Conference of the European-Society-for-Medical-Oncology (ESMO)
会议日期	SEP 19-21, 2020
会议地点	ELECTR NETWORK
英文摘要	Introduction: Sintilimab plus chemotherapy significantly prolonged progression-free survival (PFS) compared with chemotherapy alone in nonsquamous NSCLC in the ORIENT-11 study. Updated overall survival (OS) and PFS data and corresponding biomarker analyses are reported here. Methods: In this study, a total of 397 patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC were assigned to sintilimab plus chemotherapy combination treatment (combo) group or placebo plus chemotherapy treatment group. The patients were stratified by programmed death-ligand 1 (PD-L1) expression levels. Immune signature profiles from tumor RNA sequencing and PD-L1 immunohistochemistry were correlated with clinical outcome to identify predictive biomarkers. Results: As of January 2021, with median follow-up of 22.9 months, median OS was significantly improved in the combo group compared with the placebo plus chemotherapy treatment group (not reached versus 16.8 mo; hazard ratio [HR] = 0.60, 95% confidence interval [CI]: 0.45-0.79, p = 0.0003). High or medium immune cell infiltration was strongly associated with improved PFS in the combo group, in contrast to absent or low immune cell infiltration, which suggests that chemotherapy could not prime immune deserts to obtain benefit from programmed cell death protein-1 inhibition. In particular, high major histocompatibility complex (MHC) class II presentation pathway expression was significantly correlated with prolonged PFS (HR = 0.32, 95% CI: 0.19-0.54, p < 0.0001) and OS (HR = 0.36, 95% CI: 0.20-0.64, p = 0.0005) in the combo group. Importantly, patients with low or absent PD L1 but high MHC class II expression could still benefit from the combo treatment. In contrast, MHC class I antigen presentation pathway was less relevant in this combination setting. Conclusions: The addition of sintilimab to chemotherapy resulted to significantly longer OS in nonsquamous NSCLC. Expression of MHC class II antigen presentation pathway could identify patients benefiting most from this combination. (c) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
英文关键词	Nonsquamous NSCLC Sintilimab RNA sequencing MHC class-II antigen presentation pathway Predictive biomarker
来源出版物	JOURNAL OF THORACIC ONCOLOGY
ISSN	1556-0864
EISSN	1556-1380
出版年	2021
卷号	16
期号	12
出版者	ELSEVIER SCIENCE INC
类型	Article; Proceedings Paper
语种	英语
开放获取类型	hybrid
收录类别	SCI-E ; CPCI-S
WOS记录号	WOS:000721176100018
WOS关键词	CLASS-II ; CHEMOTHERAPY ; EXPRESSION ; SAFETY
WOS类目	Oncology ; Respiratory System
WOS研究方向	Oncology ; Respiratory System
资源类型	会议论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/379057
作者单位	[Yang, Yunpeng; Fang, Wenfeng; Zhang, Li] Sun Yat Sen Univ, Canc Ctr, Collaborat Innovat Ctr Canc Med, Med Oncol Dept,State Key Lab Oncol South China, 651 Dongfeng East Rd, Guangzhou 510060, Guangdong, Peoples R China; [Sun, Jiya; Mancao, Christoph; Peng, Bo; Xu, Wei] Innovent Biol Inc, New Drug Biol & Translat Med, Suzhou, Peoples R China; [Wang, Zhehai] Shandong Canc Hosp, Med Oncol Dept, Jinan, Peoples R China; [Fang, Jian] Peking Univ, Canc Hosp, Dept Thorac Oncol 2, Beijing, Peoples R China; [Yu, Qitao] Guangxi Med Univ, Affiliated Tumor Hosp, Dept Resp Oncol, Nanning, Peoples R China; [Han, Baohui] Shanghai Chest Hosp, Dept Resp, Shanghai, Peoples R China; [Cang, Shundong] Zhengzhou Univ, Henan Prov Hosp, Dept Oncol, Zhengzhou, Peoples R China; [Chen, Gongyan] Harbin Med Univ, Canc Hosp, Dept Resp, Harbin, Peoples R China; [Mei, Xiaodong] Anhui Prov Hosp, Dept Resp, Hefei, Peoples R China; [Yang, Zhixiong] Guangdong Med Univ, Affiliated Hosp, Dept Oncol, Zhanjiang, Peoples R China; [Ma, Rui] Liaonin...
推荐引用方式 GB/T 7714	Yang, Yunpeng,Sun, Jiya,Wang, Zhehai,et al. Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC in the Phase 3 ORIENT-11 Study[C]:ELSEVIER SCIENCE INC,2021.