While TMB has shown promise as a biomarker, it is not without limitations. The reliability of TMB can be influenced by the heterogeneity of tumors, differences in sequencing methods, and the cutoff values used to define "high" TMB. Additionally, TMB alone may not fully predict response to checkpoint inhibitors, and it is often used in combination with other biomarkers, such as PD-L1 expression, for a more comprehensive assessment.
