Population pharmacokinetics and exposure-response analysis of durvalumab in patients with resectable stage II to IIIB (N2) NSCLC in the phase III AEGEAN study.

ABSTRACT:

Aims

In the AEGEAN study, perioperative durvalumab plus platinum-based neoadjuvant chemotherapy for patients with resectable stage II to IIIB (N2) non-small-cell lung cancer (NSCLC) demonstrated a favourable benefit-risk profile. This study evaluated population pharmacokinetics (PopPK) and exposure-response (ER) relationships of durvalumab in patients with resectable NSCLC.

Methods

The durvalumab PopPK model was updated by integrating PK data from the AEGEAN study. Individual exposure metrics were derived from empirical Bayes estimates for ER analyses relating to safety (adverse events [AEs]) and efficacy (pathological complete response [pCR] and event-free survival [EFS]).

Results

A two-compartment model with a time-dependent clearance adequately characterized durval

SUBMITTER: Zhao X 

PROVIDER: S-EPMC12930014 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature