A Multi-Institutional Study Underscores the Potential Predictive...

A Multi-Institutional Study Underscores the Potential Predictive Biomarkers for Clinical Decision-Making

By Pharma Tech Outlook | Monday, January 13, 2020

Luca Quagliata, PhD, Global Head of Medical Affairs for Clinical NGS and Oncology

The study will pave the way for better collaboration between pathologists and oncologists, leading to enhanced quality of care for patients.

FREMONT, CA: Immune checkpoint inhibitor (ICI) therapy has been bolstered by the emergence of tumor mutation burden (TMB) as a potential biomarker. A new study regarding the combination of TMB with PD-L1 expression data has boosted its relevance in the oncology sector, especially in identifying patients likely to respond positively to ICI therapy. It will be presented at the 31st European Congress Pathology (ECP) congress in Nice, France.

Luca Quagliata, PhD, global head of medical affairs for clinical NGS and Oncology, Thermo Fisher Scientific, and co-author of the study said, “As we expand our understanding about how combined biomarker testing can help predict response to immunotherapies, we are moving fast toward a future in which this combined approach will more effectively guide clinical decision-making for cancer patients.”

The study led by Dr. Philip Jermann, Head of Molecular Assay Development, Institute of Medical Genetics and Pathology, University Hospital Basel, evaluated TMB retrospectively in 76 metastatic non-small cell lung cancer (NSCLC) patients undergoing ICI therapy. It identified a cutoff to subcategorize them into low, intermediate, and high TMB. According to the results, 64 percent of the patients with high TMB responded positively to ICI therapy when compared to 29 percent of the patients with low TMB. The patients with TMB also exhibited considerably longer progression-free survival (PFS) and overall survival (OS).

The PD-L1 positive samples with high tumor mutational load showed the highest response rate compared to PD-L1 negative and TMB-low and TMB-intermediate population. According to the researchers, the findings bolster the complementary use of biomarkers and prognostic factors to enhance the precision of patient stratification.

The promising outcomes show a correlation between high mutational load and increased response rate to immune checkpoint inhibitor therapies, bolstering the presence of TMB in routine diagnostics. The study supports the potential of TMB as a predictive biomarker. According to the study, the integration of different biomarkers, such as PD-L1 may facilitate precise predictions to guide clinical decision-making. The researchers are also testing other biomarkers such as T-cell receptor (TCR) and gene expression profiling in the tumor microenvironment to enhance predictive power in multivariate molecular profiling.

The study is one of the first regarding TMB to evaluate the performance of Thermo Fisher’s Oncomine Tumor Mutation Load Assay, which can generate in-house results in almost the same time as spent by labs to develop PD-L1 data, allowing the parallel analysis of both tests. The findings agree with the recent clinical research study led by Dr. Paul Hofman, which revealed that TMB assessments performed using Oncomine Tumor Mutation Load Assay provided comparable results and predictive value to a commonly ordered, commercial next-generation sequencing (NGS) panel.

Even though the two studies were conducted independently using distinct immune checkpoint inhibitors, they found the same cutoff to define low, intermediate, and high TMB. The study will potentially equip oncologists, clinical staff, and molecular pathologists with the capability of conducting TMB analysis in-house by jointly deciding the best treatment option for their patients. The collaboration between oncologists and pathologists facilitated by the study will significantly enhance the quality of patient care.

Thermo Fisher Scientific collaborates with its customers to make the world clean, safe, and healthy, assisting them in enhancing diagnostics, improving medicine delivery to market, and increasing laboratory productivity. The innovative technologies, purchasing convenience, and comprehensive support offered by its premier brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services, are aimed at bolstering the capabilities of its customers. For emerging as one of the biggest innovative forces in pharma and life sciences domain, Thermo Fisher Scientific was recognized as one of the “Top 10 Pharma & Life Science Tech Solution Providers - 2017” by APAC CIO Outlook.

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