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Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11)
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2020-10-01 , DOI: 10.1016/j.jtho.2020.07.014 Yunpeng Yang 1 , Zhehai Wang 2 , Jian Fang 3 , Qitao Yu 4 , Baohui Han 5 , Shundong Cang 6 , Gongyan Chen 7 , Xiaodong Mei 8 , Zhixiong Yang 9 , Rui Ma 10 , Minghong Bi 11 , Xiubao Ren 12 , Jianying Zhou 13 , Baolan Li 14 , Yong Song 15 , Jifeng Feng 16 , Juan Li 17 , Zhiyong He 18 , Rui Zhou 19 , Weimin Li 20 , You Lu 21 , Yingyi Wang 22 , Lijun Wang 23 , Nong Yang 24 , Yan Zhang 25 , Zhuang Yu 26 , Yanqiu Zhao 27 , Conghua Xie 28 , Ying Cheng 29 , Hui Zhou 30 , Shuyan Wang 30 , Donglei Zhu 30 , Wen Zhang 31 , Li Zhang 1
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2020-10-01 , DOI: 10.1016/j.jtho.2020.07.014 Yunpeng Yang 1 , Zhehai Wang 2 , Jian Fang 3 , Qitao Yu 4 , Baohui Han 5 , Shundong Cang 6 , Gongyan Chen 7 , Xiaodong Mei 8 , Zhixiong Yang 9 , Rui Ma 10 , Minghong Bi 11 , Xiubao Ren 12 , Jianying Zhou 13 , Baolan Li 14 , Yong Song 15 , Jifeng Feng 16 , Juan Li 17 , Zhiyong He 18 , Rui Zhou 19 , Weimin Li 20 , You Lu 21 , Yingyi Wang 22 , Lijun Wang 23 , Nong Yang 24 , Yan Zhang 25 , Zhuang Yu 26 , Yanqiu Zhao 27 , Conghua Xie 28 , Ying Cheng 29 , Hui Zhou 30 , Shuyan Wang 30 , Donglei Zhu 30 , Wen Zhang 31 , Li Zhang 1
Affiliation
INTRODUCTION
Sintilimab, an anti-programmed death 1 antibody, plus pemetrexed and platinum had shown promising efficacy for nonsquamous non-small cell lung cancer in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to compare the efficacy and safety of sintilimab with placebo, both in combination with such chemotherapy. (ClinicalTrials.gov: NCT03607539) METHODS: A total of 397 patients with previously untreated locally advanced or metastatic nonsquamous NSCLC without sensitizing epidermal growth factor receptor or anaplastic lymphoma kinase genomic aberration were randomized (2:1 ratio) to receive either sintilimab 200 mg or placebo plus pemetrexed and platinum Q3W for 4 cycles, followed by sintilimab or placebo plus pemetrexed therapy. Crossover or treatment beyond disease progression was allowed. The primary endpoint was progression-free survival (PFS) by independent radiographic review committee. RESULTS
As of Nov. 15, 2019, the median follow-up was 8.9 months. The median PFS was significantly longer in the sintilimab-combination group than that in the placebo-combination group (8.9 vs. 5.0 months; HR, 0.482, 95%CI, 0.362 to 0.643; p < 0.00001). The confirmed objective response rate was 51.9 % (95% CI, 45.7% to 58.0%) in sintilimab-combination group and 29.8% (95% CI, 22.1% to 38.4%) in placebo-combination group. The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group. CONCLUSIONS
In Chinese patients with previously untreated locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy of pemetrexed and platinum resulted in significantly longer PFS than that of chemotherapy alone with manageable safety profiles.
更新日期：2020-10-01
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