Todua Clinic, Tbilisi, Georgia.
LTD High Technology Hospital Med Center, Batumi, Georgia.
Lung Cancer. 2024 Jul;193:107821. doi: 10.1016/j.lungcan.2024.107821. Epub 2024 May 13.
OBJECTIVES: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, assessed cemiplimab (anti-programmed cell death protein 1) plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations, regardless of histology or PD-L1 expression levels. We report results from subgroup analysis of patients with PD-L1 expression ≥ 1 %. MATERIALS AND METHODS: Patients were randomized to receive cemiplimab 350 mg or placebo with chemotherapy every 3 weeks for up to 108 weeks. Overall survival (OS), progression-free survival (PFS), overall response rates (ORRs), patient-reported outcomes (PROs), and safety were assessed. RESULTS: Of the 327 patients with PD-L1 ≥ 1 % (466 in the overall study), 217 received cemiplimab plus chemotherapy and 110 received chemotherapy alone. After median follow-up of 28.0 months, median OS for cemiplimab plus chemotherapy was 23.5 months (95 % confidence interval [CI]: 20.9-27.2) vs. 12.1 months (95 % CI: 10.1-15.7) for chemotherapy alone (hazard ratio [HR] = 0.51, 95 % CI: 0.38-0.69, P < 0.0001); median PFS was 8.3 months (95 % CI: 6.7-10.8) versus 5.5 months (95 % CI: 4.3-6.2; HR = 0.48; 95 % CI: 0.37-0.62, P < 0.0001), and ORR was 47.9 % versus 22.7 %, respectively. PRO results favored cemiplimab plus chemotherapy over chemotherapy alone. Improved efficacy over chemotherapy alone was observed in both squamous and non-squamous histology. Safety was consistent with previous reports. CONCLUSION: In this subgroup analysis from EMPOWER-Lung 3 part 2, cemiplimab plus chemotherapy demonstrated clinical benefit over chemotherapy alone in patients with advanced squamous or non-squamous NSCLC with PD-L1 ≥ 1 %.
目的：EMPOWER-Lung 3 第 2 部分（NCT03409614）是一项双盲、安慰剂对照的 3 期研究，评估了西米普利单抗（抗程序性细胞死亡蛋白 1）联合化疗与单独化疗在晚期非小细胞肺癌（NSCLC）患者中的疗效，这些患者无 EGFR、ALK 或 ROS1 异常，无论组织学或 PD-L1 表达水平如何。我们报告了 PD-L1 表达≥1%患者亚组分析的结果。
材料和方法：患者被随机分配接受西米普利单抗 350mg 或安慰剂联合化疗，每 3 周 1 次，最多 108 周。评估总生存期（OS）、无进展生存期（PFS）、总缓解率（ORR）、患者报告的结局（PRO）和安全性。
结果：在 PD-L1≥1%的 327 名患者（整个研究中为 466 名）中，217 名患者接受了西米普利单抗联合化疗，110 名患者接受了单独化疗。在中位随访 28.0 个月后，西米普利单抗联合化疗的中位 OS 为 23.5 个月（95%置信区间[CI]：20.9-27.2），而单独化疗为 12.1 个月（95%CI：10.1-15.7）（风险比[HR]0.51，95%CI：0.38-0.69，P<0.0001）；中位 PFS 为 8.3 个月（95%CI：6.7-10.8）与 5.5 个月（95%CI：4.3-6.2；HR0.48；95%CI：0.37-0.62，P<0.0001），ORR 分别为 47.9%和 22.7%。PRO 结果表明西米普利单抗联合化疗优于单独化疗。在鳞状和非鳞状组织学中均观察到优于单独化疗的疗效。安全性与之前的报告一致。
结论：在 EMPOWER-Lung 3 第 2 部分的这项亚组分析中，与单独化疗相比，西米普利单抗联合化疗在 PD-L1≥1%的晚期鳞状或非鳞状 NSCLC 患者中显示出临床获益。
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