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The use of TMB mutation load detection as a biomarker for the selection of pembrolizumab (Keytruda™) as a treatment for adult and pediatric patients with unresectable or metastatic solid tumors has been approved by the FDA.
The approval was based in part on the phase 2 KEYNOTE-158 study, which showed an association between high TMB and the response rate to treatment (ORR) with the PD-1 inhibitor in patients with various solid tumours.
TMB refers to the total number of somatic mutations present in the genome of a tumour.
Tumours with a high mutation load may have a higher proportion of neo-antigens and, by extension, are expected to be more immunogenically active than tumours with a comparatively lower mutation load.