Abstract

Background: Non-small cell lung cancer (NSCLC) patients with high tumour mutational burden (TMB) have shown improved outcomes when treated with anti-PD-1/L1 therapies. This biomarker is not well correlated with tumour PD-L1 expression, and may identify a unique subset of patients to enrich for outcomes to these therapies. Collection of tumour biopsies can be challenging with technical issues of specimen quality, tumour cell abundance, and use of archival vs fresh biopsy significantly reducing rates of reportable results. Circulating tumour DNA (ctDNA) analysis using plasma samples is less invasive and may produce reportable TMB scores with a higher success rate than tissue. Here we assess whether a plasma-based TMB assay can improve rates of reportable TMB scores in NSCLC patients treated in the first-line setting in a phase 3 clinical trial.

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