Conference Program

Statistical Challenges in Evaluating Tumor Mutation Burden (TMB) Biomarker (303710)

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*Zhiheng Xu, US Food and Drug Administration 

Keywords: TMB, Validation, Genome

Tumor mutational burden (TMB), the biomarker representing the total number of somatic mutations in a defined region of a tumor genome, has been recently approved for patient selection in tissue-agnostic setting. In this talk, I will discuss some of statistical challenges in evaluating the analytical and clinical studies for TMB validation from regulatory perspective.