Journal of the American Medical Association Manuscript Supports the
Value of Real-World Evidence as a Novel Method to Advance Research and
Discovery
CAMBRIDGE, Mass. & NEW YORK–(BUSINESS WIRE)–Foundation Medicine and Flatiron Health today announced 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. 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.
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.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a
transformation in cancer care in which treatment is informed by a deep
understanding of the genomic changes that contribute to each patient’s
unique cancer. The company offers a full suite of comprehensive genomic
profiling assays to identify the molecular alterations in a patient’s
cancer and match them with relevant targeted therapies, immunotherapies
and clinical trials. Foundation Medicine’s molecular information
platform aims to improve day-to-day care for patients by serving the
needs of clinicians, academic researchers and drug developers to help
advance the science of molecular medicine in cancer. For more
information, please visit www.FoundationMedicine.com
or follow Foundation Medicine on Twitter (@FoundationATCG).
About Flatiron Health
Flatiron Health is a healthcare technology and services company focused
on accelerating cancer research and improving patient care. Flatiron’s
platform enables cancer researchers and care providers to learn from the
experience of every patient. Currently, Flatiron partners with over 280
community cancer practices, seven major academic research centers and
over 15 of the top therapeutic oncology companies. For more information,
please visit www.flatiron.com
or follow Flatiron on Twitter (@FlatironHealth).
Contacts
Foundation Medicine
Lee-Ann Murphy, 617-245-3077
pr@foundationmedicine.com
Flatiron Health
David Cirilli, 646.727.0063
pr@flatironhealth.com