Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial.

D+CT had a trend for OS improvement versus CT that did not reach statistical significance.

与CT相比，D+CT在总生存（OS）改善方面呈现趋势，但未达到统计学显著性。

This article reports prespecified OS analyses after long-term follow-up (median >5 y).

本文报告了长期随访后的预设总生存分析（中位随访时间超过5年）。

Methods

A total of 1013 patients were randomized (1:1:1) to T+D+CT, D+CT, or CT, stratified by tumor cell programmed cell death ligand-1 (PD-L1) expression (≥50% versus <50%), disease stage (IVA versus IVB), and tumor histologic type (squamous versus nonsquamous).

共有1013名患者按1:1:1的比例随机分配至T+D+CT、D+CT或CT组，根据肿瘤细胞程序性死亡配体-1（PD-L1）表达水平（≥50%对比<50%）、疾病分期（IVA对比IVB）以及肿瘤组织学类型（鳞状对比非鳞状）进行分层。

Serious adverse events were collected during follow-up.

随访期间收集了严重不良事件。

Results

After a median follow-up of 63.4 months across all arms, T+D+CT had sustained OS benefit versus CT (hazard ratio[HR] = 0.76, 95% confidence interval[CI]: 0.64-0.89; 5-y OS: 15.7% versus 6.8%).

在所有组别中位随访63.4个月后，T+D+CT与CT相比，总生存期（OS）持续获益（风险比[HR] = 0.76，95%置信区间[CI]：0.64-0.89；5年OS：15.7%对比6.8%）。

OS improvement with D+CT versus CT (HR = 0.84, 95% CI: 0.72-1.00; 5-y OS: 13.0%) was consistent with the primary analysis.

D+CT与CT相比，总生存期有所改善（HR=0.84，95%置信区间：0.72-1.00；5年总生存率：13.0%），这与主要分析结果一致。

OS benefit with T+D+CT versus CT remained more pronounced in nonsquamous (HR = 0.69, 95% CI: 0.56-0.85) versus squamous (HR = 0.85, 95% CI: 0.65-1.10) mNSCLC.

在非鳞状细胞型mNSCLC中，T+D+CT与CT相比，总生存期获益更为显著（HR=0.69，95%置信区间：0.56-0.85），而在鳞状细胞型mNSCLC中，总生存期获益较小（HR=0.85，95%置信区间：0.65-1.10）。

OS benefit with T+D+CT versus CT was still evident regardless of PD-L1 expression, including patients with PD-L1 tumor cell less than 1%, and remained evident in STK11-mutant (nonsquamous), KEAP1-mutant, and KRAS-mutant (nonsquamous) mNSCLC.

T+D+CT与CT相比，无论PD-L1表达如何，总生存（OS）获益仍然明显，包括PD-L1肿瘤细胞小于1%的患者，并在STK11突变（非鳞状）、KEAP1突变和KRAS突变（非鳞状）的晚期非小细胞肺癌（mNSCLC）中保持明显。

No new safety signals were identified.

未发现新的安全信号。

Conclusions

After a median follow-up of more than 5 years, T+D+CT had durable long-term OS benefit versus CT, supporting its use as first-line treatment in mNSCLC, including in patient subgroups with harder-to-treat disease.

经过超过5年的中位随访期，T+D+CT与CT相比，具有持久的长期总生存益处，支持其作为晚期非小细胞肺癌一线治疗的使用，包括在那些更难治疗的患者亚组中。