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Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2019-09-28 , DOI: 10.1056/nejmoa1910231
Matthew D Hellmann 1 , Luis Paz-Ares 1 , Reyes Bernabe Caro 1 , Bogdan Zurawski 1 , Sang-We Kim 1 , Enric Carcereny Costa 1 , Keunchil Park 1 , Aurelia Alexandru 1 , Lorena Lupinacci 1 , Emmanuel de la Mora Jimenez 1 , Hiroshi Sakai 1 , Istvan Albert 1 , Alain Vergnenegre 1 , Solange Peters 1 , Konstantinos Syrigos 1 , Fabrice Barlesi 1 , Martin Reck 1 , Hossein Borghaei 1 , Julie R Brahmer 1 , Kenneth J O'Byrne 1 , William J Geese 1 , Prabhu Bhagavatheeswaran 1 , Sridhar K Rabindran 1 , Ravi S Kasinathan 1 , Faith E Nathan 1 , Suresh S Ramalingam 1
Affiliation  

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.).

中文翻译:

Nivolumab 加 Ipilimumab 治疗晚期非小细胞肺癌。

背景 在一项涉及晚期非小细胞肺癌 (NSCLC) 患者的早期研究中,纳武利尤单抗联合易普利姆玛治疗的反应率优于纳武利尤单抗单药治疗,尤其是在表达程序性死亡配体 1 (PD- L1)。需要数据来评估纳武利尤单抗联合易普利姆玛在 NSCLC 患者中的长期益处。方或化疗。PD-L1 表达水平低于 1% 的患者以 1:1:1 的比例随机分配接受纳武单抗加易普利姆玛、纳武单抗加化疗或单独化疗。所有患者既往未接受过化疗。这里报告的主要终点是 PD-L1 表达水平为 1% 或更高的患者与化疗相比,纳武利尤单抗加易普利姆玛的总生存期。结果 在 PD-L1 表达水平≥1% 的患者中,纳武利尤单抗加易普利姆玛的中位总生存期为 17.1 个月(95% 置信区间 [CI],15.0 至 20.1)和 14.9 个月(95% CI , 12.7 至 16.7) 与化疗 (P = 0.007),2 年总生存率分别为 40.0% 和 32.8%。纳武单抗加易普利姆玛的中位缓解持续时间为 23.2 个月,化疗为 6.2 个月。在 PD-L1 表达水平低于 1% 的患者中也观察到了总体生存获益,中位持续时间为 17.2 个月(95% CI,12.8 至 22. 0) 纳武利尤单抗加易普利姆玛和 12.2 个月 (95% CI, 9.2 至 14.3) 化疗。在试验的所有患者中,纳武利尤单抗加易普利姆玛的中位总生存期为 17.1 个月(95% CI,15.2 至 19.9),化疗为 13.9 个月(95% CI,12.2 至 15.1)。纳武利尤单抗加易普利姆玛治疗组中发生 3 级或 4 级治疗相关不良事件的患者百分比为 32.8%,化疗组为 36.0%。结论 与 NSCLC 患者的化疗相比,纳武利尤单抗加易普利姆玛一线治疗的总生存期更长,与 PD-L1 表达水平无关。长期随访未出现新的安全问题。(由 Bristol-Myers Squibb 和 Ono Pharmaceutical 资助;CheckMate 227 ClinicalTrials.gov 编号,NCT02477826。)。
更新日期:2019-11-21
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