Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study.

We report the final analysis of PEARL.

我们报告了PEARL的最终分析结果。

Methods

Adults (N = 669) with previously untreated stage IV mNSCLC were randomized (1:1) to durvalumab 20 mg/kg every four weeks or chemotherapy every three weeks for four to six cycles.

先前未接受治疗的IV期mNSCLC成人患者（N=669）按1:1比例随机分配至每四周接受20 mg/kg的durvalumab治疗或每三周接受化疗，持续四到六个周期。

The dual primary endpoints were overall survival(OS) in the population with PD-L1 TC of 25% or higher and OS in the population at low risk of early mortality (LREM) with PD-L1 TC of 25% or higher.

双重主要终点是PD-L1肿瘤细胞（TC）表达≥25%的患者群体的总生存（OS）和早期死亡风险低（LREM）的PD-L1 TC≥25%的患者群体的总生存（OS）。

Results

Durvalumab was associated with a numerical reduction in the risk of death versus chemotherapy in the 25% and higher PD-L1 TC population (OS hazard ratio[HR] = 0.84, 95% confidence interval[CI]: 0.71-0.99, p = 0.037; median OS 14.6 months, 95% CI: 12.2-16.9 versus 12.8 months, 95% CI: 10.1-14.7, respectively).

在PD-L1肿瘤细胞(TC)表达量为25%及以上的患者群体中，与化疗相比，durvalumab与死亡风险的数值降低相关（总生存期风险比[HR] = 0.84，95%置信区间[CI]：0.71-0.99，p = 0.037；中位总生存期为14.6个月，95% CI: 12.2-16.9，与化疗的12.8个月，95% CI: 10.1-14.7相比）。

In the 25% and higher PD-L1 TC low risk of early mortality population the OS hazard ratiofor durvalumab versus chemotherapy was 0.96 (95% CI: 0.79-1.15, p = 0.628); median OS 14.6 months (95% CI: 12.6-17.2) versus 15.0 months (95% CI: 13.1-16.8), respectively.

在PD-L1肿瘤细胞(TC)表达量为25%及以上且早期死亡风险较低的患者群体中，durvalumab与化疗的总生存期风险比为0.96（95%置信区间[CI]: 0.79-1.15，p = 0.628）；中位总生存期分别为14.6个月（95% CI: 12.6-17.2）和15.0个月（95% CI: 13.1-16.8）。

In the safety population, the incidenceof grade 3 or 4 treatment-related adverse events was 15.5% (durvalumab) and 45.9% (chemotherapy).

在安全性人群中，3级或4级治疗相关不良事件的发生率为15.5%（durvalumab）和45.9%（化疗）。

Conclusions

Durvalumab did not statistically significantly improve OS versus chemotherapy as first-line treatment in patients with mNSCLC and 25% and higher PD-L1 TC.

在PD-L1肿瘤细胞阳性表达≥25%的晚期非小细胞肺癌患者中，与化疗相比，durvalumab作为一线治疗并未显著改善总生存期。

The numerical improvement in OS was consistent with previous studies of first-line immune checkpoint inhibitormonotherapy in patients with mNSCLC.

总生存期（OS）的数值改善与先前关于一线免疫检查点抑制剂单药治疗晚期非小细胞肺癌（mNSCLC）患者的研究结果一致。