Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis.

Here we report clinical outcomes from a pooled analysis of patients with metastatic NSCLC and tumor programmed death-ligand 1 (PD-L1) lower than 1% treated with first-line nivolumab plus ipilimumab with or without two cycles of chemotherapy versus up to four cycles of chemotherapy in the randomized phase 3 CheckMate 227 and CheckMate 9LA studies.

在这里，我们报告了 CheckMate 227 和 CheckMate 9LA 研究中，一线使用 nivolumab 加上 ipilimumab，有或没有两个周期化疗治疗的转移性 NSCLC 患者，以及最多四个周期化疗治疗的临床结果，这些患者的肿瘤程序性死亡配体 1（PD-L1）表达低于 1%。

Methods

Patients were aged 18 years or older and had stage IV or recurrent NSCLC with no sensitizing EGFR/ALK alterations.

患者年龄在18岁或以上，患有IV期或复发性非小细胞肺癌（NSCLC），且无敏感性EGFR/ALK改变。

Assessments included overall survival(OS), progression-free survival(PFS), objective response rate, duration of response, and safety.

评估内容包括总生存（OS）、无进展生存（PFS）、客观缓解率、缓解持续时间及安全性。

Results

In patients with tumor PD-L1 lower than 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 322) versus chemotherapy (n = 315) arms, median OS was 17.4 versus 11.3 months, respectively, (hazard ratio[HR] = 0.64, 95% confidence interval[CI]: 0.54-0.76; 5-y OS rate, 20% versus 7%) at a median follow-up of 73.7 months.

在肿瘤PD-L1表达低于1%的患者中，接受纳武单抗联合伊匹木单抗（无论是否联合化疗，n=322）与单纯化疗（n=315）治疗的中位总生存期分别为17.4个月和11.3个月（风险比[HR]=0.64，95%置信区间[CI]：0.54-0.76；5年总生存率分别为20%和7%），随访中位时间为73.7个月。

The OS benefit was observed across key subgroups, including difficult-to-treat populations such as those with baseline brain metastases (HR = 0.44, 95% CI: 0.26-0.75) or squamous NSCLC (HR = 0.51, 95% CI: 0.36-0.72).

在包括基线时有脑转移（HR=0.44，95% CI: 0.26-0.75）或鳞状非小细胞肺癌（HR=0.51，95% CI: 0.36-0.72）等难治性人群的关键亚组中，观察到总生存期的益处。

In the overall pooled population, the median PFS was 5.4 versus 4.9 months (HR = 0.72, 95% CI: 0.60-0.87; 5-y PFS rate, 9% versus 2%), the objective response ratewas 29% versus 22%, and the median duration of response was 18.0 versus 4.6 months.

在总体合并人群中，中位无进展生存期（PFS）为5.4个月对比4.9个月（HR=0.72，95%置信区间：0.60-0.87；5年PFS率，9%对比2%），客观缓解率为29%对比22%，缓解持续时间的中位数为18.0个月对比4.6个月。

No new safety signals were observed.

未观察到新的安全信号。

Conclusions

Nivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 lower than 1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need.

在肿瘤PD-L1表达低于1%的转移性非小细胞肺癌患者中，纳武利尤单抗联合伊匹木单抗，无论是否联合化疗，均能提供长期且持久的临床益处，这支持将此治疗策略作为这一高未满足医疗需求人群的一线治疗选择。

clinical_trial_registrations

NCT02477826, NCT03215706.

NCT02477826, NCT03215706。