■在非小细胞肺癌(NSCLC)中,表皮生长因子受体(EGFR)突变是典型的致癌驱动突变。只有约12%的EGFR突变患者具有外显子20插入突变,这是EGFR突变NSCLC中第三常见的突变。Amivantamab,EGFR和MET原癌基因,受体酪氨酸激酶(MET)双特异性抗体,已被批准用于EGFR外显子20插入(E20I)突变的NSCLC患者。在这项研究中,我们描述了现实世界,Amivantamab在E20I突变患者中的单中心疗效和安全性数据。
■本研究包括EGFRE20I突变的转移性NSCLC患者。从2018年1月至2022年6月,作为临床试验或早期接入计划(EAP)的一部分,在三星医学中心对接受amivantamab治疗的EGFRE20I突变患者进行了分析。我们收集了患者的特征[年龄,性别,吸烟史,突变的位置,转移部位,程序性死亡配体1(PD-L1)表达状态,等。]并分析了按PD-L1表达状态分层的无进展生存期(PFS)和总生存期(OS),共突变,如肿瘤蛋白p53(TP53),和转移部位。
■共分析了42例患者,其中16名患者参加了1期研究,26例患者通过EAP接受了amivantamab。有14例(33%)患者部分缓解,18例(43%)病情稳定,和10(24%)患者的疾病进展。客观反应率(ORR)为33%,疾病控制率(DCR)为76%。通过划分突变位置已知的31名患者的近和远环来分析PFS。两组PFS[中位数(范围):11.8(2.3-21.3)与11.3(3.4-19.2)个月,P=0.69]。对于29例TP53突变患者,两组之间的PFS没有显着差异[中位数(范围):5.9(0-18.0)与12.6(6.9-18.3)个月,P=0.11]。在分析37例PD-L1表达数据的PFS时,PD-L1(+)患者预后不良[中位数(范围):11.3(5.0-17.6)与19.5(5.3-33.7)个月,P=0.04;危险比(HR),0.44;95%置信区间(CI):0.20-0.98]。
■对于EGFRE20I突变的非小细胞肺癌的真实世界人群,证实了阿米坦单抗的疗效。PD-L1状态可能是一个糟糕的预测因素,这应该进一步验证。
UNASSIGNED: In non-small cell lung cancer (NSCLC), the epidermal growth factor receptor (EGFR) mutation is a representative oncogenic driver mutation. Only about 12% of EGFR mutation patients have the exon 20 insertion mutation, which is the third most frequent mutation among EGFR mutation NSCLC. Amivantamab, an EGFR and MET proto-oncogene, receptor tyrosine kinase (MET) bispecific antibody, was approved for NSCLC patients with the EGFR exon 20 insertion (E20I) mutation. In this study, we described the real-world, single-center efficacy and safety data of amivantamab in E20I mutation patients.
UNASSIGNED: This study included metastatic NSCLC patients with EGFR E20I mutations. From January 2018 to June 2022, patients with EGFR E20I mutations who were treated with amivantamab were analyzed at Samsung Medical Center as part of the clinical trial or the early access program (EAP). We collected the patients\' characteristics [age, sex, smoking history, location of mutation, sites of metastasis, programmed death-ligand 1 (PD-L1) expression status, etc.] and analyzed progression-free survival (PFS) and overall survival (OS) stratified by PD-L1 expression status, co-mutation such as tumor protein p53 (TP53), and metastasis sites.
UNASSIGNED: A total of 42 patients were analyzed, of which 16 patients were enrolled in the phase 1 study, and 26 patients received amivantamab through EAP. There were 14 (33%) patients with partial remission, 18 (43%) patients with stable disease, and 10 (24%) patients with disease progression. The objective response rate (ORR) was 33%, and the disease control rate (DCR) was 76%. PFS was analyzed by dividing the near and far loop for 31 patients whose mutation location was known. The two groups had no statistically significant difference in PFS [median (range): 11.8 (2.3-21.3) vs. 11.3 (3.4-19.2) months, P=0.69]. For 29 patients with TP53 mutation data, there was no significant difference in PFS between the two groups [median (range): 5.9 (0-18.0) vs. 12.6 (6.9-18.3) months, P=0.11]. When analyzing PFS in 37 patients with PD-L1 expression data, PD-L1 (+) patients showed a poor prognosis [median (range): 11.3 (5.0-17.6) vs. 19.5 (5.3-33.7) months, P=0.04; hazard ratio (HR), 0.44; 95% confidence interval (CI): 0.20-0.98].
UNASSIGNED: The efficacy of amivantamab was confirmed for the real-world population for EGFR E20I-mutated NSCLC. PD-L1 status could be a poor predictive factor, which should be further validated.