Population Pharmacokinetics of Osimertinib in Patients With Non-Small Cell Lung Cancer.

ABSTRACT: Population pharmacokinetics (popPK) modeling for osimertinib, a third-generation, irreversible, oral epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitizing mutations and EGFR T790M, was previously reported utilizing AURA and AURA2 data (advanced non-small cell lung cancer [NSCLC]). We report updated popPK modeling incorporating AURA3 and FLAURA data (advanced NSCLC); model validation used ADAURA data (resected stage IB-IIIA NSCLC). Updated popPK analyses were based on patients from AURA (n = 599), AURA2 (n = 210), AURA3 (n = 277), and FLAURA (n = 278) using a linear one-compartmental disposition model for osimertinib and its metabolite, AZ5104, with first-order oral absorption. A full covariate model, using M

SUBMITTER: Johnson M 

PROVIDER: S-EPMC12035414 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature