Abstract
9017Background: Immune checkpoint inhibitor (ICPI) therapies, including nivolumab and pembrolizumab, have been FDA-approved in squamous and non-squamous non-small cell (LC). Current IHC based diagnostics are challenged by assay and slide scoring issues, and more robust and comprehensive biomarkers of ICPI efficacy are needed. Methods: Comprehensive genomic profiling (CGP) was performed on FFPE specimens during the course of clinical care. TMB (mutations/Mb) was assessed as the number of somatic, coding, base substitution and indel alterations per Mb of genome. The top quartile of LC was classified as TMB high. Microsatellite instable (MSI-H) or stable (MSS) status was determined using a proprietary computational algorithm. Results: TMB was similar across all LC histologies, but elevated compared to an average TMB of 7.3 for all 60,000+ samples in the database. TMB was consistently low in LC harboring known drivers, with the exception of BRAF or KRAS mutant tumors. (See Table.) 22/5,895 LC cases (0.4%) ass...
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