Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1.

Here, we report the five-year outcomes.

在这里，我们报告了五年的结果。

Methods

Patients were randomized 1:1 to cemiplimab 350 mg intravenously every three weeks for two years or the investigator's choice of chemotherapy.

患者按1:1比例随机接受cemiplimab 350 mg静脉注射，每三周一次，持续两年，或选择研究者指定的化疗方案。

The primary endpoints were overall survival(OS) and progression-free survival.

主要终点是总生存（OS）和无进展生存期。

Results

A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355).

共有712名患者被随机分配接受cemiplimab治疗（n=357）或化疗（n=355）。

The median duration of follow-up was 59.6 months (interquartile range: 55.1-66.7 months) at the data cutoff (January 16, 2024).

在数据截止日期（2024年1月16日），随访的中位持续时间为59.6个月（四分位数范围：55.1-66.7个月）。

In patients with verified 50% or higher PD-L1 (n = 565), median OS was 26.1 months for cemiplimab versus 13.3 months for chemotherapy (hazard ratio= 0.59, 95% confidence interval[CI]: 0.48-0.72); the median progression-free survivalwas 8.1 months versus 5.3 months (hazard ratio= 0.50, 95% confidence interval: 0.41-0.61); and the objective response ratewas 46.5% versus 20.6%.

在PD-L1表达≥50%的患者(n = 565)中，cemiplimab的中位总生存期为26.1个月，化疗为13.3个月（风险比=0.59，95%置信区间[CI]: 0.48-0.72）；无进展生存期的中位数为8.1个月对比5.3个月（风险比=0.50，95%置信区间: 0.41-0.61）；客观缓解率为46.5%对比20.6%。

The five-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy.

cemiplimab的五年总生存概率为29.0%，化疗为15.0%。

Improved survival outcomes were observed with both squamous and nonsquamous histology, and increasing activity of cemiplimab was correlated with higher PD-L1 expression, with the highest PD-L1 expression having the best outcome.

观察到鳞状和非鳞状组织学类型的患者生存结果均有所改善，cemiplimab的活性增加与PD-L1表达水平升高相关，PD-L1表达最高的患者预后最佳。

The safety profile remains consistent with previous results.

安全性特征与以往结果保持一致。

Grade 3 or higher treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.

cemiplimab治疗相关的3级或更高级别的不良事件发生在18.3%的患者中，化疗组为39.9%。

Conclusions

At five-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with 50% or higher PD-L1.

在五年随访中，对于PD-L1表达水平为50%或更高的晚期非小细胞肺癌患者，cemiplimab单药一线治疗与化疗相比，继续显示出持久的临床益处。

Patients with 90% or higher PD-L1 derived the largest clinical benefits.

具有90%或更高PD-L1表达的患者获得了最大的临床益处。