Névine Zariffa

Circulating tumor DNA (ctDNA) is an emerging biomarker with potential as an intermediate end point for regulatory decision-making in oncology drug development. Prior studies have shown that decreases in ctDNA levels are associated with improved overall survival (OS), but questions remain regarding the optimal timing of plasma collection and how to define molecular response (MR) across different treatment modalities.

The recent approval of programmed cell death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors as frontline therapy for advanced non–small-cell lung cancer (NSCLC) has changed the treatment paradigm for this disease.1-6 However, not all patients respond to immune checkpoint inhibitors (ICI), and some may experience clinically significant, and sometimes long-lived, toxicity.7 Disease response is currently assessed with clinical and radiographic evaluation, with the first imaging assessment...