Aumoltertinib is a third-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors and has achieved potent efficacy for advanced EGFR-mutated non-small cell lung cancer patients.
Phase 2 non-randomized clinical trial was conducted at 10 centers in China. Patients were enrolled from July 2021 to August 2022 and data cutoff date was October 2024. These patients received Aumoltertinib, 165mg, orally once daily until disease progression or unacceptable toxic effects. The findings of the study suggest that high-dose Aumoltertinib is associated with long-term survival benefit among patients with Untreated EGFR-variant NSCLC and brain metastases.
In this study, 63 patients were enrolled which included 39 females. The primary end point was 12-month progression-free survival rate assessed by investigators. Secondary end points were intracranial PFS, systemic objective response rate etc. The exploratory end points were biomarkers associated with anti-tumor activity. This trial evaluated the activity and safety of high-dose Aumoltertinib in patients with untreated EGFR-variant non-small cell lung cancer and brain metastases. EGFR variants are common gene alterations in lung adenocarcinoma and Central Nervous System (CNS) being one of the most common metastatic sites in patients with EGFR-variant NSCLC. CNS metastases can be detected in 25% to 40% of this population at the time of diagnosis and going up to 50% over the course of disease.
Although this study delivered promising results but it had limitation. It was a single-arm study withiut a control group and thus, leading to potential selection bias. Then, tumor response was assessed by investigators without independent central review. The study only enrolled Chinese patients and the results need to be validated in other populations. Also, the relatively small sample size diminishes the statistical power to come up with any conclusions. Long-term survival results will be reported in the future.
The information shared in this blog is for educational purposes only.
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