Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial
| Autor: | Sai-Hong Ignatius Ou, Xingxiang Xu, Yuan Chen, Chuan Li, Ying Cheng, Ziping Wang, Changan Sun, Kai Wang, Jianhua Chen, Qiong Wu, Zhehai Wang, R. Guo, Te Chun Hsia, Zhuang Yu, Jian Fang, Shaoshui Chen, Haihua Yang, Yong Song, Chin-Chou Wang, Xiaorong Dong, Jianxing He, Her-Shyong Shiah, Ping Wang, Cheng-Ta Yang, Hongying Wei, Yuping Sun, Viola W. Zhu, Jianhua Shi, Guojun Zhang, Wu Chou Su, Jifeng Feng, Jianying Zhou, Jiuwei Cui, Nong Yang, Shun Lu, Yanping Hu, Qiming Wang, Hongming Pan, Chao-Hua Chiu, Gee-Chen Chang, You Lu, James Chih-Hsin Yang |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Pulmonary and Respiratory Medicine
Oncology medicine.medical_specialty Indoles Lung Neoplasms medicine.drug_class EGFR T790M Tyrosine-kinase inhibitor Carcinoma Non-Small-Cell Lung Internal medicine medicine Clinical endpoint Humans In patient Epidermal growth factor receptor Alanine aminotransferase Adverse effect Protein Kinase Inhibitors Acrylamides Aniline Compounds biology business.industry Disease progression respiratory tract diseases ErbB Receptors Pyrimidines Mutation biology.protein business |
| Zdroj: | Journal of Thoracic Oncology. 17:411-422 |
| ISSN: | 1556-0864 |
| Popis: | Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation EGFR tyrosine kinase inhibitor (TKI) with revealed activity against EGFR-sensitizing mutations and EGFR T790M mutation.Patients with locally advanced or metastatic NSCLC who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy were enrolled in this registrational phase 2 trial of aumolertinib at 110 mg orally once daily (NCT02981108). The primary end point was objective response rate (ORR) by independent central review.A total of 244 patients with EGFR T790M-positive NSCLC were enrolled. The ORR by independent central review was 68.9% (95% confidence interval [CI]: 62.6-74.6). The disease control rate was 93.4% (95% CI: 89.6-96.2). The median duration of response was 15.1 months (95% CI: 12.5-16.6). The median progression-free survival was 12.4 months (95% CI: 9.7-15.0). Among 23 patients with assessable central nervous system (CNS) metastases, the CNS-ORR and CNS-disease control rate were 60.9% (95% CI: 38.5-80.3) and 91.3% (95% CI: 72.0-98.9), respectively. The median CNS-duration of response was 12.5 months (95% CI: 5.6-not reached). Treatment-related adverse events of more than or equal to grade 3 occurred in 16.4% of the patients, with the most common being increased blood creatine phosphokinase level (7%) and increased alanine aminotransferase level (1.2%). The relative dose density of aumolertinib was 99.2% in this study.Aumolertinib is an effective and well-tolerated third-generation EGFR TKI for patients with EGFR T790M-positive advanced NSCLC after disease progression on first- and second-generation EGFR TKI therapy. On the basis of these findings, aumolertinib was approved in the People's Republic of China for patients positive for EGFR T790M NSCLC. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|