Osimertinib: A Review in Previously Untreated, EGFR Mutation-Positive, Advanced NSCLC

Plain Language Summary Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is associated with a poor prognosis. In about 17% of Caucasian patients and 39% of Asian patients with NSCLC, mutations in the epidermal growth factor receptor (EGFR) gene drive tumour growth. EGFR tyrosine kinase inhibitors (EGFR-TKIs) improve clinical outcomes in patients with NSCLC harbouring EGFR mutations. Osimertinib (Tagrisso(R)) is the first approved third-generation EGFR-TKI. When given to patients with previously untreated, EGFR mutation-positive, advanced NSCLC, osimertinib delayed disease progression or death by approximate to 9 months and extended overall survival by approximate to 7 months relative to first-generation EGFR-TKIs. Overall, the tolerability of osimertinib was similar to that of the first-generation EGFR-TKIs. Osimertinib is an effective, valuable treatment for patients with previously untreated, EGFR mutation-positive, advanced NSCLC. Activating mutations in the epidermal growth factor receptor (EGFR) gene have been identified as key oncogenic drivers of non-small cell lung cancer (NSCLC). Osimertinib (Tagrisso(R)) is an orally administered, third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) that is widely approved for the first-line treatment of advanced NSCLC with activating EGFR mutations. In the pivotal phase III FLAURA trial, osimertinib significantly prolonged progression-free survival (PFS) and overall survival (OS) relative to first-generation EGFR-TKIs in patients with previously untreated, EGFR mutation-positive, advanced NSCLC. Osimertinib also significantly prolonged central nervous system (CNS) PFS in patients with CNS metastases at trial entry. Osimertinib had a generally manageable tolerability profile; the majority of adverse events considered to be possibly related to treatment were of mild to moderate severity. Osimertinib represents a valuable targeted therapeutic for use in adults with previously untreated, EGFR mutation-positive, advanced NSCLC.

Automated summary

Osimertinib is an effective treatment for non-small cell lung cancer, prolonging survival and showing good tolerability in patients.