Population Pharmacokinetics and Exposure-Response Analysis of First-Line Osimertinib Plus Chemotherapy in Patients with EGFR-Mutated Advanced NSCLC.

ABSTRACT: Osimertinib, a third-generation, central nervous system-active epidermal growth factor receptor-tyrosine kinase inhibitor, potently and selectively inhibits epidermal growth factor receptor-tyrosine kinase inhibitor sensitizing and T790M resistance mutations, with efficacy in epidermal growth factor receptor-mutated non-small cell lung cancer. In FLAURA2 (NCT04035486), first-line osimertinib plus platinum-pemetrexed chemotherapy showed significant improvement in progression-free survival over osimertinib monotherapy in patients with epidermal growth factor receptor-mutated advanced non-small cell lung cancer. A population pharmacokinetics analysis using cumulative pharmacokinetics data from 2,196 patients across six studies (AURA, AURA2, AURA3, ADAURA, FLAURA, and FLAURA2) assessed pharmac

SUBMITTER: Yang J 

PROVIDER: S-EPMC12598126 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature