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莫博赛替尼和 Amivantamab 治疗既往接受过铂类化疗的晚期非小细胞肺癌患者的疗效:一项间接治疗比较。

Efficacy of Mobocertinib and Amivantamab in Patients With Advanced Non-Small Cell Lung Cancer With EGFR Exon 20 Insertions Previously Treated With Platinum-Based Chemotherapy: An Indirect Treatment Comparison.

机构信息

Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA.

Evidera, Inc, Paris, France.

出版信息

Clin Lung Cancer. 2024 May;25(3):e145-e152.e3. doi: 10.1016/j.cllc.2023.11.011. Epub 2023 Dec 4.

Abstract

INTRODUCTION

Exon 20 insertions (ex20ins) mutations of the EGFR gene account for 1% to 2% of all non-small-cell lung cancers (NSCLCs). Targeted therapies have been developed to treat this cancer type but have not been studied in head-to-head trials. Our objective was to use a matching-adjusted indirect comparison (MAIC) to assess the efficacy of mobocertinib and amivantamab in patients with NSCLC EGFR ex20ins mutations who were previously treated with platinum-based chemotherapy.

MATERIALS AND METHODS

An unanchored MAIC was conducted to estimate the treatment effects of mobocertinib and amivantamab using individual-level data from the mobocertinib phase I/II single-arm trial (NCT02716116) and published data from the amivantamab single-arm CHRYSALIS trial (NCT02609776). Confirmed overall response rate (cORR), progression-free survival (PFS), overall survival (OS), and duration of response (DoR) were assessed.

RESULTS

Both trials were comparable in terms of study population, study design, and outcome definitions and included 114 patients who received mobocertinib and 114 patients who received amivantamab. After MAIC weighting, all reported baseline characteristics were balanced between mobocertinib and amivantamab. The weighted odds ratio (OR) [95% confidence interval (CI)] comparing mobocertinib to amivantamab was 0.56 (0.30-1.04) for independent review committee (IRC)-assessed cORR and 0.98 (0.53-1.82) for investigator (INV)-assessed cORR. The weighted hazard ratio (HR) comparing mobocertinib to amivantamab was 0.74 (0.51-1.07) for IRC-assessed PFS, 0.92 (0.57-1.48) for OS, and 0.59 (0.30-1.18) for INV-assessed DoR.

CONCLUSION

MAIC analysis showed that mobocertinib and amivantamab had similar efficacy in patients with NSCLC harboring EGFR ex20ins mutations whose disease progressed during or after platinum-based chemotherapy. These findings may benefit patients by supporting future treatment options.

摘要

简介

表皮生长因子受体(EGFR)基因外显子 20 插入(ex20ins)突变占非小细胞肺癌(NSCLC)的 1%至 2%。已经开发了针对这种癌症类型的靶向治疗方法,但尚未在头对头试验中进行研究。我们的目的是使用匹配调整间接比较(MAIC)来评估先前接受过铂类化疗的 NSCLC EGFR ex20ins 突变患者使用莫博赛替尼和 amivantamab 的疗效。

材料和方法

使用莫博赛替尼 I/II 期单臂试验(NCT02716116)的个体水平数据和 amivantamab 单臂 CHRYSALIS 试验(NCT02609776)的已发表数据进行无锚定 MAIC,以估计莫博赛替尼和 amivantamab 的治疗效果。评估了确认的总体缓解率(cORR)、无进展生存期(PFS)、总生存期(OS)和缓解持续时间(DoR)。

结果

两项试验在研究人群、研究设计和结局定义方面具有可比性,共纳入 114 例接受莫博赛替尼治疗和 114 例接受 amivantamab 治疗的患者。经过 MAIC 加权后,莫博赛替尼和 amivantamab 之间所有报告的基线特征均达到平衡。独立审查委员会(IRC)评估的 cORR 中,莫博赛替尼与 amivantamab 的加权比值比(OR)[95%置信区间(CI)]为 0.56(0.30-1.04),研究者(INV)评估的 cORR 为 0.98(0.53-1.82)。IRC 评估的 PFS 中,莫博赛替尼与 amivantamab 的加权 HR 为 0.74(0.51-1.07),OS 为 0.92(0.57-1.48),INV 评估的 DoR 为 0.59(0.30-1.18)。

结论

MAIC 分析表明,在铂类化疗期间或之后疾病进展的 NSCLC 患者中,莫博赛替尼和 amivantamab 的疗效相似,这一发现可能通过支持未来的治疗选择使患者受益。

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