First data on a novel blood-based assay for the measurement of tumor mutation burden (TMB) codeveloped by Roche, Basel Switzerland, and Foundation Medicine, Cambridge, Mass, were presented during the recent annual meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain.

The data were generated as part of a broad, ongoing effort to advance the personalization of cancer immunotherapy by delivering treatment options tailored to the specific immune biology associated with a person’s tumor. In pursuit of this goal, Roche is currently developing 20 cancer immunotherapy medicines across nine types of cancer, and in more than 50 combinations with other medicines. Roche is committed to advancing the science of cancer immunotherapy and exploring multiple biomarker approaches, including PD-L1 immunohistochemistry, tumor gene expression, RNA sequencing, and tumor mutational burden (TMB).

The data presented at ESMO demonstrated that a blood-based test can measure TMB with a high degree of precision and accuracy. TMB is a quantitative clinical marker that measures the number of mutations within a tumor genome. TMB has been found to be an indicator of the likelihood of progression-free survival benefit from immunotherapies when used alone (monotherapy) in patients with non-small cell lung cancer.

Until now, TMB could only be measured using a tumor biopsy. By using a blood-based testing approach, it may be possible to extend TMB testing to more patients, including those who are unable to undergo an invasive tumor biopsy, or where tissue is unavailable or of insufficient size to evaluate.

“Pursuing next-generation biomarker development is a critical component of our cancer immunotherapy strategy,” says Sandra Horning, MD, Roche’s chief medical officer and head of global product development. “Biomarkers will not only improve our understanding of immune biology but will ultimately help match our therapies and combinations to the people most likely to benefit.”

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