Population pharmacokinetic and exposure-response analyses from ALTA-1L: Model-based analyses supporting the brigatinib dose in ALK-positive NSCLC.

ABSTRACT: The ALK in Lung Cancer Trial of brigAtinib in First Line (ALTA-1L) compared brigatinib versus crizotinib in anaplastic lymphoma kinase (ALK) inhibitor-naive patients with ALK+ non-small cell lung cancer (NSCLC). A population pharmacokinetic (PK) model was used to estimate brigatinib exposures for exposure-efficacy and exposure-safety analyses in ALTA-1L. A previously developed population PK model for brigatinib was applied to estimate brigatinib PK parameters. Relationships between static (time-independent) and dynamic (time-varying) exposure metrics and efficacy (progression-free survival [PFS], objective response rate [ORR], and intracranial ORR [iORR]) and safety outcomes (selected grade ≥2 and grade ≥3 adverse events [AEs]) were evaluated using logistic regression and time-to-event ana

SUBMITTER: Gupta N 

PROVIDER: S-EPMC9099121 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature