Treatment-Free Survival Over 6 Years of Follow-up in Patients With Metastatic NSCLC Treated With First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in CheckMate 227 Part 1.

In CheckMate 227 Part 1, nivolumab plus ipilimumab reported long-term durable overall survival(OS) benefit versus chemotherapy in patients with metastatic NSCLC.

在CheckMate 227第一部分中，纳武利尤单抗联合伊匹木单抗在转移性非小细胞肺癌患者中报告了与化疗相比的长期持续总生存（OS）获益。

Here, we report updated long-term TFS results.

在这里，我们报告了更新的长期TFS结果。

Methods

This analysis included all patients randomized (tumor programmed death ligand 1 [PD-L1] expression ≥1% and <1%).

这项分析包括了所有随机分配的患者（肿瘤程序性死亡配体1 [PD-L1] 表达≥1%且<1%）。

TFS was estimated as the restricted-mean survival time (between Kaplan-Meier curves for time to treatment discontinuation and time to subsequent systemic therapy or death) over 6 years after randomization.

治疗自由生存期（TFS）被估计为限制性平均生存时间（在治疗中断时间和随后系统治疗或死亡时间的Kaplan-Meier曲线之间）在随机化后6年内的估计值。

TFS was further divided into periods with or without ongoing toxicity (grade 3 or greater treatment-related adverse events) and estimated over 2 and 6 years after randomization.

治疗自由生存期（TFS）进一步被划分为有无持续性毒性（3级或更高级别的治疗相关不良事件）的时期，并在随机化后2年和6年进行估计。

Results

At 6 years after randomization (minimum follow-up: 73.5 months [∼6.1 years]), the estimated OS rate was 20% with nivolumab plus ipilimumab versus 11% with chemotherapy; 13% versus 2% of patients were treatment free.

随机分组后6年（最少随访时间：73.5个月[约6.1年]），使用纳武利尤单抗联合伊匹木单抗的患者总生存估计率为20%，而化疗组为11%；分别有13%和2%的患者在治疗中。

The 6-year mean TFS was 12.2 versus 5.0 months (difference 7.2 [95% confidence interval: 5.4-9.2]), with 17% versus 7% of the 6-year period spent in TFS.

6年的平均无进展生存期为12.2个月对比5.0个月（差异7.2个月，95%置信区间：5.4-9.2），在6年的时间里，分别有17%和7%的时间处于无进展生存状态。

The 6-year mean TFS without grade 3 or greater treatment-related adverse events was 11.6 versus 4.8 months (difference, 6.9 [95% confidence interval: 5.1-8.9]).

在没有3级或更高级别治疗相关不良事件的情况下，6年的平均无进展生存期为11.6个月，而化疗组为4.8个月（差异，6.9个月 [95%置信区间：5.1-8.9]）。

The proportion of mean TFS time increased from 15% of a 2-year to 17% of a 6-year period with nivolumab plus ipilimumab but decreased from 14% to 7% with chemotherapy.

在接受纳武单抗联合伊匹木单抗治疗的情况下，平均无进展生存期的比例从2年的15%增加到6年的17%，而在化疗组中，这一比例从14%下降到7%。

Similar results were observed by tumor PD-L1 expression.

通过肿瘤PD-L1表达观察到了相似的结果。

Conclusions

Nivolumab plus ipilimumab improved TFS versus chemotherapy, regardless of tumor PD-L1 expression, supporting its use as an efficacious first-line treatment for metastatic NSCLC.

无论肿瘤PD-L1表达如何，纳武单抗联合伊匹木单抗改善了治疗失败时间（TFS），与化疗相比，支持其作为转移性NSCLC有效的一线治疗手段。