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Implementing TMB measurement in clinical practice: considerations on assay requirements
Reinhard Büttner1, John W Longshore2, Fernando López-Ríos3
1Institute of Pathology, University Hospital Cologne, Cologne, Germany.
ESMO Open
|February 23, 2019
Summary
High tumor mutational burden (TMB) predicts response to immunotherapy. Standardizing TMB assessment is crucial for reliable clinical decision-making in precision medicine.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Immune checkpoint inhibitor immunotherapy offers significant benefits across various cancers.
- Predictive biomarkers are needed to identify patients most likely to respond to immunotherapy.
- High tumor mutational burden (TMB) is increasingly recognized as a key biomarker for immunotherapy response.
Purpose of the Study:
- To review factors influencing the adoption of TMB measurement into clinical practice.
- To provide an understanding of TMB assay considerations throughout the sample journey.
- To suggest principles for effective implementation of TMB assays in clinical settings.
Main Methods:
- Comprehensive tumor characterization using genomic, transcriptomic, and proteomic approaches.
- Assessment of TMB through whole genome, whole exome, or targeted gene panel sequencing.
- Analysis of factors impacting TMB assay workflow, results, and data interpretation.
Main Results:
- TMB is a quantitative measure of mutations in tumor tissue, implementable in molecular/pathology labs.
- Lung cancer and melanoma, with high TMB, have seen significant clinical practice changes due to immunotherapy.
- Current TMB assessment lacks standardization, hindering reliable and comparable results across studies.
Conclusions:
- Standardizing TMB assessment is essential for its use as a biomarker influencing treatment decisions.
- Consideration of factors like sample type, quality, sequencing, and bioinformatics is vital for TMB assay implementation.
- Effective implementation of TMB assays can aid and optimize treatment decisions in clinical practice.
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