PO.CTP01.03 · 进行中的临床试验

Neratinib在EGFR外显子18突变非小细胞肺癌二线患者中的疗效

Neratinib efficacy in second line patients with EGFR exon 18-mutant non-small-cell lung cancer

编号 CT212 展板 7 时间 4/21 09:00–12:00 区域 Section 51 主讲 Steve Shen, PhD

分会场 Phase II and Phase III Clinical Trials in Progress

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作者与单位 Authors & Affiliations

Steve Shen¹, Wenfeng Fang², Ning Li³, Runxiang Yang⁴, Ying Cheng⁵, Baogang Liu⁶, Haiyong Wang⁷, Lin Wu⁸, Qiming Wang⁸

¹Convalife Pharmaceuticals Co., Ltd., Shanghai, China,²Sun Yat-sen University Cancer Center, Guangzhou, China,³Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China,⁴Yunan Cancer Hospital, Kunming, China,⁵Jilin Cancer Hospital, Changchun, China,⁶Harbin Medical University Cancer Hospital, Harbin, China,⁷Shandong Cancer Hospital, Shandong, China,⁸Hunan Cancer Hospital, Changsha, China

摘要 Abstract

中文摘要

背景：在NSCLC患者中，EGFR外显子18突变约占所有EGFR突变的3-5%，且与不良预后相关。在2期SUMMIT全球篮子试验中，29例携带EGFR外显子18突变的转移性NSCLC患者接受了neratinib单药治疗。客观缓解率（ORR）为35%。然而，该研究仅纳入了1例（4.5%）亚洲个体。因此，迫切需要探索neratinib在携带EGFR外显子18突变的中国NSCLC患者中的疗效。方法：Neratinib于2024年在中国以商品名Hannaijia（汉纳佳）获批。本研究（NCT06029816）计划纳入14例一线标准化疗失败的EGFR外显子18突变NSCLC患者。这项2期研究的主要终点为研究者根据RECIST v1.1评估的ORR，次要终点包括DCR（疾病控制率）、PFS（无进展生存期）。结果：截至目前，14例携带外显子18突变的晚期NSCLC患者在标准一线治疗失败后接受了Neratinib（Hannaijia®）治疗。总体而言，ORR为64.3%（9例PR、4例SD、1例PD）。疾病控制率为92.9%（13例患者）。中位PFS为12.78个月（95% CI，5.62个月至NE）。100%的患者发生了常见的1-2级治疗相关不良事件（AE）。腹泻（CTCAE 2-3级）最为常见，发生于50.0%的患者，经洛哌丁胺干预后可在3天内得到控制。截至目前，所有患者均未发生4-5级AE。结论：在标准一线治疗失败后接受Neratinib（Hannaijia®）治疗，在EGFR外显子18突变的NSCLC中显示出可耐受的安全性和令人鼓舞的初步疗效。本研究有望为携带EGFR外显子18突变的中国NSCLC患者提供更多治疗选择。

查看英文原文 English abstract

Background: In NSCLC patients, mutations in EGFR exon 18 account for approximately 3-5% of all EGFR mutations and are associated with a poor prognosis. In phase 2 SUMMIT global basket trial, 29 metastatic NSCLC patients with EGFR exon 18 mutations received neratinib monotherapy in global. The objective response rate (ORR) was 35%. However, only 1 (4.5%) Asian individual enrolled in this study. Therefore, there is an urgent need to explore the effect of neratinib in Chinese NSCLC patients with EGFR exon 18 mutation. Methods: Neratinib was approved with brand Hannaijia in 2024 in China. Planned 14 patients with EGFR exon 18-mutated NSCLC who had failed first-line standard chemotherapy were enrolled in this study (NCT06029816) . The primary endpoint of this phase 2 study is the ORR by the investigator according to RECISTv1.1 and the secondary endpoints are including DCR (Disease Control Rate), PFS (Progression-Free Survival). Results: To date, 14 advanced NSCLC patients with exon 18 mutations after receiving Neratinib (Hannaijia®) treatment following the failure of standard first-line therapy. Overall, ORR was 64.3% (9 PR ,4 SD,1 PD). The disease control rate was 92.9% (13 patients). The median PFS was 12.78 months (95% Cl,5.62 months to NE). The common 1-2 grade treatment-related adverse events (AEs) occur in 100% of patients. Diarrhea (CTCAE Grade 2-3) was the most common, which occurred in 50.0% of patients, and can be managed within 3 days after loperamide intervention. To date, there have been no grade 4- 5 AEs in any of the patients. Conclusion: Neratinib (Hannaijia®) treatment following the failure of standard first-line therapy demonstrated tolerable safety and encouraging preliminary efficacy in NSCLC with EGFR exon 18 mutations. This study is expected to provide more treatment options for Chinese patients with NSCLC who have EGFR exon 18 mutations.

利益披露 Disclosure

S. Shen, None.. W. Fang, None.. N. Li, None.. R. Yang, None.. Y. Cheng, None.. B. Liu, None.. H. Wang, None.. L. Wu, None.. Q. Wang, None.

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