Molecular response cutoffs and ctDNA collection timepoints influence on interpretation of associations between early changes in ctDNA and overall survival in patients treated with anti-PD(L)1 and/or chemotherapy.

ABSTRACT:

Background

Circulating tumor DNA (ctDNA) is a promising intermediate end point for oncology drug development, potentially accelerating regulatory approvals by providing early insights into treatment response. However, challenges remain in standardizing ctDNA assessment, including optimal blood collection timing and defining molecular response (MR) cutoffs. The ctDNA for Monitoring Treatment Response (ctMoniTR) project, led by Friends of Cancer Research, aggregates patient-level data from clinical trials to evaluate associations between ctDNA changes and overall survival (OS).

Methods

This analysis included four randomized clinical trials of patients with advanced non-small cell lung cancer (aNSCLC) treated with either anti-programmed death (ligand) 1 (anti-PD(L)1) therapy (w

SUBMITTER: Andrews HS 

PROVIDER: S-EPMC12458711 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature