On April 9, 2019 Foundation Medicine and Flatiron Health reported the publication of study results in the Journal of the American Medical Association validating that real-world clinico-genomic data obtained during the course of routine patient care can yield scientifically and clinically meaningful insights (Press release, Foundation Medicine, APR 9, 2019, View Source [SID1234535090]). These insights can serve as real-world evidence to advance research and discovery in oncology, and may also ultimately inform clinical guidelines. The continuously-updated, de-identified clinico-genomic database includes patient outcomes data processed from patients in Flatiron Health’s network of oncology clinics, linked with comprehensive genomic profiling (CGP) results from Foundation Medicine’s FoundationCORE database.
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The findings demonstrate the feasibility of creating a de-identified clinico-genomic database (CGDB) and validate the potential of such real-world data for understanding and optimizing personalized cancer care, including, for example, biomarkers of response to immunotherapy treatment. The study linked clinical data from the electronic health records (EHRs) of 28,998 patients from 275 oncology practices in Flatiron Health’s network across the United States with genomic data from Foundation Medicine CGP testing. Among 4,064 patients with non-small cell lung cancer (NSCLC), exploratory analyses recapitulated previously described associations between clinical and genomic characteristics, between driver mutations and response to targeted therapy, and between tumor mutation burden (TMB) and response to immunotherapy.
"The publication of our validation study in a high-profile journal not only validates the ability of a real-world clinico-genomic database to yield scientifically and clinically-relevant findings, but also the potential for this novel approach to significantly impact our understanding of personalized medicine. This represents a major milestone in our mission to leverage regulatory-grade, real-world data to advance cancer care," stated Gaurav Singal, MD, chief data officer at Foundation Medicine. "As the dataset continues to grow, we expect it will advance therapeutics development, optimize clinical trial design and execution, and ultimately even support clinical decision making, enabling a more efficient way to evaluate new medicines and accelerate their availability for patients who need them."
In addition to demonstrating the scientific validity of the database for rigorous research, the study findings confirmed and extended several biomarker hypotheses in oncology. Corroborating recent clinical trial data, high TMB was shown to be associated with both longer duration on anti-PD-1/PD-L1 therapy and improved overall survival (OS) from treatment initiation. In addition, this retrospective real-world analysis re-demonstrated the importance of genomic biomarker-guided targeted treatment in NSCLC: among patients with genomic alterations known to drive tumor growth, treatment with agents targeted to these mutations was associated with prolonged survival. These findings may be extended in the future to identify additional factors associated with response to targeted therapies and immunotherapies.
"Our proof-of-principle study validated the importance of marrying tumor genomic data with clinical outcomes recorded during routine care, which represents a huge stream of data that is being generated and recorded every day, but has not yet been used meaningfully outside of patient care," said Vineeta Agarwala, MD, PhD, director of product management at Flatiron Health. "These data can inform treatment guidelines, clinical trial design, and precision drug development."
Since launching in November 2016, the CGDB now includes linked, de-identified data for more than 50,000 patients (over 6,000 with non-small cell lung cancer) and helps researchers and biopharmaceutical partners accelerate the development of targeted therapeutics and immunotherapies to treat cancer. The CGDB includes de-identified clinical data (demographic data, medication history, laboratory testing, and outcomes including survival) from Flatiron Health linked to genomic data (comprehensive genomic profiling of tumors, including genomic findings, variant annotations, and computational biomarkers such as tumor mutational burden [TMB], microsatellite instability [MSI], and loss of heterozygosity [LOH]) from Foundation Medicine across a variety of tumor types, allowing for a continuously updated, longitudinal view of a patient’s clinical, diagnostic and therapeutic journey.