Regeneron Pharmaceuticals, Inc. announced five-year results from the final pre-specified overall survival (OS) analysis of the Phase III EMPOWER-Lung 1 trial, which evaluated Libtayo (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with  greater than 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

Regeneron Pharmaceuticals，Inc.宣布了III期EMPOWER Lung 1试验最终预先指定的总生存期（OS）分析的五年结果，该试验评估了Libtayo（cemiplimab）单药治疗与化疗作为成人晚期非小细胞肺癌（NSCLC）的一线治疗，PD-L1表达大于50%，无EGFR，ALK或ROS1畸变。

The late-breaking results will be presented in an oral session at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.

最新的研究结果将在国际肺癌研究协会主办的IASLC 2024年世界肺癌会议（WCLC）上发表。

“The five-year results from EMPOWER-Lung 1 showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with PD-L1 high, advanced NSCLC, including a direct correlation between survival benefits and PD-L1 expression level,” says Ana Baramidze, MD, PhD, Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia.

“EMPOWER Lung 1的五年结果显示，与PD-L1高晚期非小细胞肺癌患者的化疗相比，一线Libtayo单药治疗具有持久的生存益处和令人印象深刻的疗效，包括生存益处与PD-L1表达水平之间的直接相关性，”佐治亚州第比利斯Todua Clinic临床研究部门负责人医学博士Ana Baramidze说。

“Furthermore, EMPOWER-Lung 1 continues to offer important new data to help doctors increase their understanding of investigational treatment strategies for patients who progress on PD-1 inhibitor monotherapy. For instance, EMPOWER-Lung 1 was one of the few trials to evaluate survival when adding chemotherapy to a PD-1 inhibitor following progression.” .

“此外，EMPOWER Lung 1继续提供重要的新数据，以帮助医生增加对PD-1抑制剂单药治疗进展患者的研究性治疗策略的理解。例如，EMPOWER Lung 1是少数在进展后向PD-1抑制剂添加化疗时评估生存率的试验之一。”。

At the five-year follow-up, Libtayo remained superior to chemotherapy in the population of patients confirmed to have  greater than 50% PD-L1 expression (using an FDA approved assay), demonstrating continued and clinically meaningful benefits consistent with the prior 1-year analysis in this study population (as previously published in The Lancet and also as previously provided in the approved label for the FDA-approved assay)..

在五年的随访中，在确诊PD-L1表达超过50%的患者群体中，Libtayo仍然优于化疗（使用FDA批准的检测方法），表明持续且具有临床意义的益处与之前在该研究人群中进行的1年分析一致（如先前在《柳叶刀》上发表的，也如先前在FDA批准的检测的批准标签中所提供的）。。

Importantly, EMPOWER-Lung 1 allowed patients who experienced disease progression to change their therapy, with those assigned to Libtayo having the option to add four cycles of chemotherapy. Among these patients (n=75), the addition of chemotherapy was associated with a 15-month median OS (95% CI: 11 to 18 months), 7-month median PFS (95% CI: 6 to 8 months) and 28% ORR (95% CI: 18% to 40%)..

重要的是，EMPOWER Lung 1允许经历疾病进展的患者改变治疗方法，分配给Libtayo的患者可以选择增加四个化疗周期。在这些患者中（n=75），化疗的增加与15个月的中位OS（95%可信区间：11至18个月），7个月的中位PFS（95%可信区间：6至8个月）和28%的ORR（95%可信区间：18%至40%）相关。。

The exploratory subgroup analysis of EMPOWER-Lung 1 also showed direct correlations between survival and disease progression benefits and PD-L1 expression level among Libtayo patients, supporting the direct correlation between tumor response and PD-L1 expression level previously observed. At five years, those with tumor PD-L1 expression of ?90% (n=99) derived the greatest benefit with a median OS of 39 months (95% CI: 23 months to not evaluable) and a 15-month median PFS (95% CI: 10 to 21 months).

EMPOWER Lung 1的探索性亚组分析也显示Libtayo患者的生存和疾病进展益处与PD-L1表达水平之间存在直接相关性，支持先前观察到的肿瘤反应与PD-L1表达水平之间的直接相关性。在五年时，那些肿瘤PD-L1表达为？90%（n=99）的中位OS为39个月（95%可信区间：23个月不可评估），中位PFS为15个月（95%可信区间：10至21个月），获益最大。

These correlations with PD-L1 expression level were not observed with chemotherapy..

化疗未观察到这些与PD-L1表达水平的相关性。。

No new safety signals were observed at five years among evaluable patients (Libtayo=356; chemotherapy=343), following a median duration of exposure of 36 weeks to Libtayo and 18 weeks to chemotherapy. Adverse events (AEs) of any grade occurred in 93% of Libtayo patients (46% greater than Grade 3) and 96% of chemotherapy patients (52% greater than Grade 3).

在接受Libtayo治疗36周和接受化疗18周的中位时间后，可评估患者（Libtayo=356；化疗=343）在五年内未观察到新的安全性信号。93%的Libtayo患者（比3级高46%）和96%的化疗患者（比3级高52%）发生任何级别的不良事件（AE）。

The most common AEs occurring in at least 10% of Libtayo patients included anemia (20%), decreased appetite (14%), fatigue (14%), pneumonia (12%), arthralgia (12%), back pain (12%), dyspnea (11%), cough (10%) and pruritus (10%). Among Libtayo patients, AEs were serious in 36% and led to permanent discontinuation in 9% and death in 10%, compared to 29%, 5% and 10% in the chemotherapy arm, respectively..

在至少10%的Libtayo患者中发生的最常见的AE包括贫血（20%），食欲下降（14%），疲劳（14%），肺炎（12%），关节痛（12%），背痛（12%），呼吸困难（11%），咳嗽（10%）和瘙痒（10%）。在Libtayo患者中，AE严重率为36%，导致永久停药9%，死亡10%，而化疗组分别为29%，5%和10%。。

Among the 75 Libtayo patients who received additive chemotherapy after disease progression, AEs of any grade occurred in 89% (36% greater than Grade 3), following a median duration of exposure of 27 weeks to Libtayo. The most common AEs included anemia (35%), alopecia (24%), diarrhea (21%), nausea (20%), neutropenia (15%) and asthenia (11%).

在疾病进展后接受加性化疗的75名Libtayo患者中，任何级别的AE发生率为89%（比3级高36%），中位暴露时间为27周。最常见的AE包括贫血（35%），脱发（24%），腹泻（21%），恶心（20%），中性粒细胞减少（15%）和虚弱（11%）。

AEs were serious in 27% of patients and led to discontinuation of treatment in 5% of patients and death in 4% of patients..

27%的患者出现严重不良事件，导致5%的患者停止治疗，4%的患者死亡。。

Additional presentations on data from Regeneron’s oncology portfolio and pipeline are being shared at WCLC.

有关Regeneron肿瘤学投资组合和管道数据的其他演示文稿正在WCLC上共享。

Condition: Non Small Cell Lung Cancer

病情：非小细胞肺癌

Type: drug

类型：药物