Tumor Mutational Burden

The FDA granted priority review to pembrolizumab for treatment of adults and children with unresectable or metastatic solid tumors that have high tissue tumor mutational burden.

Plasma-based tumor mutational burden of 16 mutations/Mb or greater appeared associated with improved PFS after first-line pembrolizumab-based treatment for metastatic non-small cell lung cancer, according to results of a single-arm, single-center study published in Clinical Cancer Research.

Tumor mutational burden seems to have arrived at an uncertain juncture in its exploration as a potential biomarker for response to immunotherapy.