The Friends of Cancer Research (Friends) recently announced the launch of phase II of its tumor mutational burden Harmonization Project, as the research team finalizes data collected from phase I in silico analysis.
“Recent data show a role for [tumor mutational burden] in identifying patients more likely to respond to immunotherapy,” said Jeffrey Allen, MD, President and Chief Executive Officer of Friends. “However, harmonizing the measurement of [tumor mutational burden] will be an important step in helping to reduce variability and optimize its use in cancer research and care. As we begin phase II, I look forward to working with our partners and the team maneuvering through the data to come to consensus solutions. This has been a truly collaborative effort.”
Phase II of the Tumor Mutational Burden Harmonization Project will be an empiric analysis of cells derived from human tumors. The working group will aim to agree upon the creation of a universal reference standard using whole-exome sequencing. Additionally, they will identify sources of variability after alignment of tumor mutational burden scores from targeted panels to the reference standard.
Phase II logistics will involve the National Cancer Institute, which will serve as the reference lab and anchor the results generated from the diagnostic partners. Additionally, SeraCare will perform the necessary sample preparations for input material, and DNAnexus will provide its cloud-based services to host the sequencing data for analyses. Completion of phase II is anticipated in early 2019.
Participants in this project include the following partners: ACT Genomics, AstraZeneca, Bristol-Myers Squibb Company, Caris Life Sciences, Columbia University, DNAnexus, EMD Serono, Inc, Foundation Medicine, Inc, Genentech, Guardant Health, Inc., Illumina, Inc, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, Merck & Co, Inc, National Cancer Institute, NeoGenomics Laboratories, Inc, OmniSeq, Personal Genome Diagnostics, Pfizer, Inc, Qiagen, Inc, Regeneron Pharmaceuticals, SeraCare, Thermo Fisher Scientific, and the U.S. Food and Drug Administration.