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Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated,EGFR-mutated,advanced non-small cell lung cancer:data froma randomized phase III trial(AENEAS)

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Cancer Communications 2024年第9期44卷 1005-1017页

作者： Shun Lu Xiaorong Dong Hong Jian Jianhua Chen Gongyan Chen Yuping Sun Yinghua Ji ZipingWang Jianhua Shi Junguo Lu Shaoshui Chen Dongqing Lv Guojun Zhang Chunling Liu Juan Li Xinmin Yu Zhong Lin Zhuang Yu ZhehaiWang Jiuwei Cui Xingxiang Xu Jian Fang Jifeng Feng Zhi Xu RuiMa Jie Hu Nong Yang Xiangdong Zhou XiaohongWu Chengping Hu Zhihong Zhang You Lu Yanping Hu Liyan Jiang Qiming wang Renhua Guo Jianying Zhou Baolan Li Chunhong Hu Wancheng Tong Helong Zhang LinMa Yuan Chen Zhijun Jie Yu Yao Longzhen Zhang JieWeng Weidong Li Jianping Xiong Xianwei Ye Jianchun Duan Haihua Yang Meili Sun HongyingWei JiaweiWei Zheyu Zhang QiongWu Department of Medical Oncology Shanghai Chest Hospital Shanghai JiaoTong UniversityShanghaiP.R.China Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhanHubeiP.R.China Department of Medical Oncology-Chest Hunan Cancer Hospital&The Affiliated Cancer Hospital of Central South University Xiangya School of MedicineChangshaHunanP.R.China Thoracic OncologyMedicine HarbinMedical University Cancer HospitalHarbinHeilongjiangP.R.China Department of Oncology Jinan Central HospitalJinanShandongP.R.China Department of Oncology First Affiliated Hospital of Xinxiang Medical UniversityXinxiangHenanP.R.China Department of Chest Medicine Beijing Cancer HospitalBeijingP.R.China Department of Internal Medicine Linyi Cancer HospitalLinyiShandongP.R.China Department of Respiratory Medicine Nantong Tumor HospitalNantongJiangsuP.R.China Department of Oncology Binzhou Medical University HospitalBinzhouShandongP.R.China Breath Internal Medicine Taizhou Hospital of Zhejiang ProvinceLinhaiZhejiangP.R.China Department of Respiration The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Department of Lung Internal Medicine Affiliated Tumor Hospital of Xinjiang Medical UniversityUrumqiXinjiangP.R.China Department of Thoracic Oncology Sichuan Cancer HospitalChengduSichuanP.R.China Thoracic Medical Oncology Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)HangzhouZhejiangP.R.China Department of Thoracic Oncology The Fifth Subsidiary Sun Yat-sen University HospitalZhuhaiGuangdongP.R.China Department of Oncology The Affiliated Hospital of QingdaoUniversityQingdaoShandongP.R.China Department of Oncology Shandong Cancer HospitalJinanShandongP.R.China Department of Oncology The First BethuneHospital of Jilin UniversityChangchunJilinP.R.China Department of Respiration Northern Jiangsu People’s Hospital Affiliated to Yangzhou UniversityYangzhouJiangsuP.R.China Department of Internal

Background:The initial randomized,double-blinded,actively controlled,phase III ANEAS study(NCT03849768)demonstrated that aumolertinib showed superior efficacy relative to gefitinib as first-line therapy in epidermal growth factor receptor(EGFR)-mutated advanced non-small cell lung cancer(NSCLC).Metastatic disease in the central nervous system(CNS)remains a challenge in the management of *** study aimed to compare the efficacy of aumolertinib versus gefitinib among patients with baseline CNS metastases in the ANEAS ***:Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded *** with asymptomatic,stable CNS metastases were ***-up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months,then every *** responsewas assessed by a neuroradiological blinded,independent central review(neuroradiological-BICR).The primary endpoint for this subgroup analysis was CNS progression-free survival(PFS).Results:Of the 429 patients enrolled and randomized in the ANEAS study,106 patients were found to have CNS metastases(CNS Full Analysis Set,cFAS)at baseline by neuroradiological-BICR,and 60 of them had CNS target lesions(CNS Evaluable for Response,cEFR).Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS(29.0 vs.8.3 months;hazard ratio[HR]=0.31;95%confidence interval[CI],0.17-0.56;Paumolertinib and gefitinib,*** risk analysis showed that the estimated probability of CNS progression without prior non-CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNSmetastases at *** new safety findings were ***:The

关键词： aumolertinib brain metastasis non-small cell lung cancer third-generation EGFR-TKI

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Antitumor activity of aumolertinib, a third-generation EGFR tyrosine kinase inhibitor, in non-small-cell lung cancer harboring uncommon EGFR mutations

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药学学报:英文版 2023年第6期13卷 2613-2627页

作者： Chen Shi Cong Zhang Zhiwen Fu Jinmei Liu Yuanfeng Zhou Bao Cheng Cong Wang Shijun Li Yu Zhang Department of Pharmacy Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430022China Hubei Province Clinical Research Center for Precision Medicine for Critical Illness Wuhan 430022China Department of Preclinical Translational Science Shanghai Hansoh Biomedical Co.Ltd.Shanghai 201203China Department of Chemistry Shanghai Hansoh Biomedical Co.Ltd.Shanghai 201203China

Uncommon epidermal growth factor receptor(EGFR) mutations account for 10% 20% of all EGFR mutations in non-small-cell lung cancer(NSCLC). The uncommon EGFR-mutated NSCLC is associated with poor clinical outcomes and generally achieved unsatisfactory effects to the current therapies using standard EGFR-tyrosine kinase inhibitors(TKIs), including afatinib and osimertinib. Therefore, it is necessary to develop more novel EGFR-TKIs to treat uncommon EGFR-mutated *** is a third-generation EGFR-TKI approved in China for treating advanced NSCLC with common EGFR mutations. However, it remains unclear whether aumolertinib is effective in uncommon EGFR-mutated NSCLC. In this work, the in vitro anticancer activity of aumolertinib was investigated in engineered Ba/F3 cells and patient-derived cells bearing diverse uncommon EGFR mutations. aumolertinib was shown to be more potent in inhibiting the viability of various uncommon EGFR-mutated cell lines than those with wild-type EGFR. And in vivo, aumolertinib could also significantly inhibit tumor growth in two mouse allograft models(V769-D770insASV and L861Q mutations) and a patientderived xenografts model(H773-V774insNPH mutation). Importantly, aumolertinib exerts responses against tumors in advanced NSCLC patients with uncommon EGFR mutations. These results suggest that aumolertinib has the potential as a promising therapeutic candidate for the treatment of uncommon EGFR-mutated NSCLC.

关键词： aumolertinib Non-small cell lung cancer Oncology Uncommon EGFR mutations Exon 20 insertion EGFR tyrosine kinase inhibitor Targeted therapy Anti-tumor activity

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aumolertinib可体内外抑制人脉络膜黑色素瘤MUM-2B细胞的增殖

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南方医科大学学报 2022年第11期42卷 1604-1610页

作者：李娟王爱莲李宁祝英泽李坤刘浩高自清蚌埠医学院第一附属医院眼科安徽蚌埠233000 蚌埠医学院药学院//安徽省生化药物工程技术研究中心安徽蚌埠233030 安徽科技学院生命与健康科学学院生物医药与健康研究院安徽凤阳233100

目的评估新型第3代表皮生长因子受体酪氨酸激酶抑制剂aumolertinib对人脉络膜黑色素瘤MUM-2B细胞增殖的影响,探索aumolertinib在眼科肿瘤治疗中的应用潜力。方法不同浓度aumolertinib(0、2、4、6、8、10μmol/L)处理MUM-2B细胞。用CCK-... 详细信息

目的评估新型第3代表皮生长因子受体酪氨酸激酶抑制剂aumolertinib对人脉络膜黑色素瘤MUM-2B细胞增殖的影响,探索aumolertinib在眼科肿瘤治疗中的应用潜力。方法不同浓度aumolertinib(0、2、4、6、8、10μmol/L)处理MUM-2B细胞。用CCK-8法检测aumolertinib对MUM-2B细胞存活率的影响;细胞集落克隆形成实验检测aumolertinib对MUM-2B细胞的增殖抑制作用;利用流式细胞分析技术检测aumolertinib对MUM-2B细胞凋亡坏死、线粒体膜电位、活性氧、细胞周期分布的影响;建立人脉络膜黑色素瘤细胞MUM-2B裸鼠荷瘤模型,设置空白组,给药组(40 mg/kg),考察aumolertinib在体内的抗肿瘤活性。结果CCK-8和细胞集落克隆形成实验的结果表明,aumolertinib显著抑制MUM-2B细胞的增殖,并呈浓度依赖性。凋亡坏死分析结果显示,当aumolertinib浓度增加到8μmol/L时,MUM-2B细胞的总凋亡率可达到76.65%。同时,MUM-2B细胞内ROS水平也随aumolertinib浓度增加显著增多。此外,aumolertinib能够有效降低MUM-2B细胞的线粒体膜电位,诱导MUM-2B细胞发生G1期周期停滞。体内研究表明,aumolertinib有效抑制肿瘤增长,而不会使动物体质量明显减轻。结论aumolertinib对人脉络膜黑色素瘤MUM-2B细胞在体外、体内试验中均发挥有效的抗肿瘤作用,在脉络膜黑色素瘤的治疗方面具有潜在用途。

关键词：人脉络膜黑色素瘤 aumolertinib 表皮生长因子受体

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