2022 World Conference on Lung Cancer (ePosters)-EP08.02-051. High-dose Aumolertinib as First-line Treatment in Patients With Brain Metastases Associated With EGFR Mutated NSCLC

EP08.02-051. High-dose Aumolertinib as First-line Treatment in Patients With Brain Metastases Associated With EGFR Mutated NSCLC

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The ongoing ACHIEVE (NCT04808752) study aims to evaluate the efficacy and safety of high-dose (165mg) aumolertinib as a first-line treatment for EGFR-mutant non-small cell lung cancer (NSCLC) patients with brain metastases (BM). NSCLC patients with EGFR mutations have a higher incidence of BM, and aumolertinib, a third-generation EGFR-TKI, has shown significant central nervous system (CNS) progression-free survival (PFS) improvement in advanced NSCLC. However, the efficacy of high-dose aumolertinib specifically in BM is uncertain.<br /><br />The rationale for high-dose aumolertinib comes from previous studies. High-dose osimertinib, a similar drug, demonstrated promising efficacy as a second-line therapy in EGFR-mutant NSCLC patients with BM and leptomeningeal metastases (LM). In addition, the maximum tolerated dose of aumolertinib has not been reached in a phase I trial, indicating its tolerability as a potential first-line treatment.<br /><br />The ACHIEVE study is a multicenter, open-label, single-arm trial that enrolled or will enroll patients in 22 sites in China. The primary objective is to assess the efficacy of 165mg aumolertinib in terms of PFS in EGFR-mutant NSCLC patients with BM. Secondary objectives include assessing intracranial PFS, overall response rate, duration of response, disease control rate, overall survival, and the safety profile of aumolertinib. Exploratory endpoints involve gene mapping before and after treatment using next-generation sequencing.<br /><br />The study began enrolling patients in May 2021 and is estimated to be completed in Q4 2022. The ACHIEVE study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. For more information on the study, visit the clinical trial registry website.<br /><br />In conclusion, the ACHIEVE study aims to evaluate the efficacy and safety of high-dose aumolertinib as a first-line treatment in EGFR-mutant NSCLC patients with BM. The study is ongoing, and its results may provide valuable insights into the use of high-dose aumolertinib in this patient population.

Asset Subtitle

Yun Fan

Meta Tag

Speaker Yun Fan

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

ACHIEVE study

NCT04808752

high-dose aumolertinib

first-line treatment

EGFR-mutant

non-small cell lung cancer

NSCLC

brain metastases

efficacy

safety