文章：

基于铂类治疗后，阿米万他单抗与泛欧肺癌患者图表回顾中激活EGFR外显子20插入突变患者的真实世界医生选择方案比较

Amivantamab Compared with Real-World Physician’s Choice after Platinum-Based Therapy from a Pan-European Chart Review of Patients with Lung Cancer and ActivatingEGFRExon 20 Insertion Mutations

原文发布日期：8 November 2023

DOI: 10.3390/cancers15225326

类型: Article

开放获取: 是

英文摘要：

Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor gene (EGFR) Exon 20 insertions (Exon20ins) at the second line and beyond (2L+) have an unmet need for new treatment. Amivantamab, a bispecific EGFR- and MET-targeted antibody, demonstrated efficacy in this setting in the phase 1b, open-label CHRYSALIS trial (NCT02609776). The primary objective was to compare the efficacy of amivantamab to the choices made by real-world physicians (RWPC) using an external control cohort from the real-world evidence (RWE) chart review study, CATERPILLAR-RWE. Adjustment was conducted to address differences in prognostic variables between cohorts using inverse probability weighting (IPW) and covariate adjustments based on multivariable regression. In total, 114 patients from CHRYSALIS were compared for 55 lines of therapy from CATERPILLAR-RWE. Baseline characteristics were comparable between the amivantamab and IPW-weighted RWPC cohorts. For amivantamab versus RWPC using IPW adjustment, the response rate ratio for the overall response was 2.14 (p= 0.0181), and the progression-free survival (PFS), time-to-next-treatment (TTNT) and overall survival (OS) hazard ratios (HRs) were 0.42 (p< 0.0001), 0.47 (p= 0.0063) and 0.48 (p= 0.0207), respectively. These analyses provide evidence of clinical and statistical benefits across multiple outcomes and adjustment methods, of amivantamab in platinum pre-treated patients with advanced NSCLC harboringEGFRExon20ins. These results confirm earlier comparisons versus pooled national registry data.

摘要翻译： 

对于携带表皮生长因子受体基因（EGFR）第20号外显子插入突变（Exon20ins）的晚期非小细胞肺癌（NSCLC）患者，在二线及后线治疗（2L+）中仍存在未满足的治疗需求。双特异性EGFR和MET靶向抗体药物Amivantamab在1b期开放性CHRYSALIS试验（NCT02609776）中已显示出对该类患者的疗效。本研究的主要目的是通过使用来自真实世界证据图表回顾研究CATERPILLAR-RWE的外部对照队列，比较Amivantamab与真实世界临床医生实际治疗方案（RWPC）的疗效。采用逆概率加权（IPW）和多变量回归协变量调整方法，对队列间预后变量的差异进行了校正。研究共纳入114例来自CHRYSALIS试验的患者，与CATERPILLAR-RWE研究中55条治疗线数据进行比较。Amivantamab组与IPW加权后的RWPC队列基线特征具有可比性。经IPW调整后，Amivantamab组相较于RWPC组的总体缓解率比值为2.14（p=0.0181），无进展生存期（PFS）、至下次治疗时间（TTNT）和总生存期（OS）的风险比（HR）分别为0.42（p<0.0001）、0.47（p=0.0063）和0.48（p=0.0207）。这些分析从多个临床终点和统计校正方法证实，Amivantamab在经铂类药物治疗、携带EGFR Exon20ins的晚期NSCLC患者中具有临床和统计学获益。该结果与此前基于国家登记数据库汇总数据的比较结论一致。

原文链接：

Amivantamab Compared with Real-World Physician’s Choice after Platinum-Based Therapy from a Pan-European Chart Review of Patients with Lung Cancer and ActivatingEGFRExon 20 Insertion Mutations