Aumolertinib: A Review in Non-Small Cell Lung Cancer

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Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest M. Shirley and S. Keam are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
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AbstractAumolertinib (formerly almonertinib; Ameile^®) is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (EGFR-TKI) that is selective for mutant EGFR over wild-type EGFR. It has been developed for the treatment of advanced EGFR mutation-positive non-small cell lung cancer (NSCLC). In the phase 3 AENEAS trial conducted in Chinese patients, aumolertinib as first-line treatment significantly prolonged progression-free survival (PFS) and duration of response (DoR) compared with gefitinib in patients with advanced EGFR mutation-positive NSCLC; overall survival (OS) data from this study are immature. In the phase 1/2 APOLLO trial, aumolertinib showed good clinical activity (based on objective response rate, PFS, DoR and OS) in Chinese patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who had progressed on or after prior EGFR-TKI therapy. Aumolertinib has a generally manageable tolerability profile; adverse events associated with wild-type EGFR inhibition (e.g. rash and diarrhoea) were less frequent with aumolertinib than gefitinib in AENEAS. Thus, aumolertinib is a promising new option for both first-line and second-line treatment in patients with advanced EGFR mutation-positive NSCLC.

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