Exposure-response analysis using time-to-event data for bevacizumab biosimilar SB8 and the reference bevacizumab.

ABSTRACT: Purpose: This analysis aimed to characterize the exposure-response relationship of bevacizumab in non-small-cell lung cancer (NSCLC) and evaluate the efficacy of SB8, a bevacizumab biosimilar, and Avastin^®, the reference bevacizumab sourced from the European Union (EU), based on the exposure reported in a comparative phase III efficacy and safety study (EudraCT, 2015-004026-34; NCT02754882). Materials and methods: The overall survival (OS) and progression-free survival (PFS) data from 224 patients with steady-state trough concentrations (C_ss,trough) were analyzed. A parametric time-to-event (TTE) model was developed using NONMEM^®, and the effects of treatments (SB8 and bevacizumab-EU) and patient demographic and clinical covariates on OS and P

SUBMITTER: Park S 

PROVIDER: S-EPMC10825021 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature