Results of the evaluation of osimertinib in previously non-treated patients with EGFR-mutated advanced NSCLC: FLAURA study
Abstract
Osimertinib is a third generation irreversible tyrosine kinase inhibitor (TKI) targeting epidermal growth factor receptor (EGFR) developed to inhibit sensitizing EGFR mutations (exon 19 deletion and L858R), prevent the occurrence of T790M mutation responsible for resistance and exert minimal effect on non-mutated (wild-type) EGFR form. Osimertinib crosses the intact hematoencephalic barrier.
In patients previously treated with TKI together with resistant T790M mutation, osimertinib demonstrated better efficacy than chemotherapy and it became a standard therapeutic option in pre-treated patients. Based on FLAURA study results, osimertinib became a new standard first-line treatment in advanced non-small cell lung cancer (NSCLC) with sensitizing mutation in EGFR gene (EGFRm NSCLC).
Osimertinib reached outstanding median length of progression free survival (PFS) of 18.9 months in comparison with 10.2 months in the EGFR-TKI comparator group. Osimertinib had comparable PFS improvement benefit in all pre-specified subgroups, including patients with brain metastases.
In a planned interim overall survival (OS) analysis, osimertinib decreased the mortality risk by 37% compared with EGFR-TKI comparator.