Since their approval in 2014, immune checkpoint inhibitors (ICIs)2 have transformed cancer care. However, the effectiveness of these agents varies greatly among different tumor types and across individual patients. This variation is a substantial challenge for optimal use of ICIs. Several response predictors have been reported, including high drug target expression (e.g., programmed death-ligand 1), increased abundance of tumor-infiltrating lymphocytes, or the presence of mutations in DNA repair genes. Yet, each predictor has limited utility as a biomarker for patient selection. A recent article in Science describes how several promising studies have now indicated that tumor mutational burden (TMB) may succeed when other response predictors have failed and may serve as a highly predictive pan-tumor biomarker of ICI sensitivity (1).
TMB is defined as the total number of nonsynonymous …
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