ALEXANDRIA, Va. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
The American Society of Clinical Oncology, Inc. (ASCO) and Foundation Medicine (NASDAQ: FMI) today announced entry into an agreement to create efficiencies for research sites participating in ASCO’s TAPUR™ Study in identifying potential participants for the study. ASCO is announcing that reports from Foundation Medicine’s comprehensive genomic profiling (CGP) assays, FoundationOne,® FoundationOne® Heme and FoundationACT® will receive the new “optimized for TAPUR reporting” designation available to entities that demonstrate reporting of nearly 75% of TAPUR-specific genes in a format that meets criteria established for the TAPUR Study. The TAPUR Study is a first-of its-kind clinical trial designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration.
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As part of this pilot program, Foundation Medicine will use its SmartTrials™ technology to create reports for TAPUR sites that identify patients who may qualify to participate in the TAPUR Study. SmartTrials is a molecularly-matched, location-specific, clinical trials database that informs physicians about clinical trials to accelerate patient enrollment. Early use of the SmartTrials report by one TAPUR site was associated with a significant increase in patient accrual with the site reporting identification of more than 60 patients whose genomic profiles matched TAPUR drug targets within a few months of implementing the SmartTrials technology. As part of this arrangement, Foundation Medicine will be launching its SmartTrials reporting to an initial pilot set of the TAPUR Study’s participating clinical sites.
“We are excited to designate Foundation Medicine’s CGP assays as providing reports that are optimized for TAPUR participation and work with Foundation Medicine to allow TAPUR Sites to incorporate SmartTrials reporting to streamline identification of patients who may qualify for the TAPUR study,” said ASCO Chief Medical Officer and TAPUR Study Principal Investigator, Richard L. Schilsky, MD, FACP, FASCO, FSCT. “It is our hope that Foundation Medicine’s unique expertise in genomics will enable many more patients to access investigational therapies through the TAPUR Study clinical trial.”
“The TAPUR Study’s innovative, biomarker-driven design will expand access for patients to innovative new targeted therapies, while enhancing the collective understanding of the genomic basis of cancer biology,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “Applying the SmartTrials reporting to the TAPUR Study can facilitate rapid and accurate patient identification, accelerating patient enrollment.”
About the TAPUR™ Study
The TAPUR Study is a non-randomized
clinical trial that aims to describe the performance (both safety and
efficacy) of commercially available, targeted anticancer drugs
prescribed for treatment of patients with advanced cancer that has a
potentially actionable genomic variant. The TAPUR Study provides
approved targeted therapies that are contributed to the program by
collaborating pharmaceutical companies, catalogues the choice of genomic
profiling test by clinical oncologists and aims to learn about the
utility of registry data to develop hypotheses for additional clinical
trials.
About ASCO:
Founded in 1964, the American Society of
Clinical Oncology, Inc. (ASCO®) is committed to making a world of
difference in cancer care. As the world’s leading organization of its
kind, ASCO represents more than 40,000 oncology professionals who care
for people living with cancer. Through research, education, and
promotion of the highest-quality patient care, ASCO works to conquer
cancer and create a world where cancer is prevented or cured, and every
survivor is healthy. ASCO is supported by its affiliate organization,
the Conquer Cancer Foundation. Learn more at www.ASCO.org,
explore patient education resources at www.Cancer.Net,
and follow us on Facebook,
Twitter,
LinkedIn,
and YouTube.
About Foundation Medicine
Foundation
Medicine (NASDAQ:FMI) 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. Foundation
Medicine’s SmartTrials program helps clinical research sponsors design,
plan and implement clinical trials using Foundation Medicine’s oncology
knowledge base and physician network. For more information, please visit http://www.FoundationMedicine.com or
follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks and SmartTrialsTM is a trademark of Foundation Medicine, Inc.
ASCO®, American Society of Clinical Oncology® and TAPUR™ are trademarks of American Society of Clinical Oncology, Inc.
Cautionary Note Regarding Forward-Looking Statements
This
press release contains "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the value and performance
capabilities of Foundation Medicine’s comprehensive genomic profiling
assays; the ability of CGP and the SmartTrials services to help
accelerate clinical trial enrollment; and the ability of a clinical
trial, including the clinical trial design, to expand access to
therapies or improve cancer care. All such forward-looking statements
are based on management's current expectations of future events and are
subject to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include the risk that Foundation Medicine's CGP
and services will not be able to identify genomic alterations in the
same manner as prior clinical data or prior experience; clinical trial
enrollment does not increase in the expected manner; and the risks
described under the caption "Risk Factors" in Foundation
Medicine's Annual Report on Form 10-K for the year ended December 31,
2016, which is on file with the Securities and Exchange Commission, as
well as other risks detailed in Foundation Medicine's subsequent filings
with the Securities and Exchange Commission. All information in this
press release is as of the date of the release, and Foundation
Medicine undertakes no duty to update this information unless required
by law.
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