CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine (NASDAQ: FMI) today announced a collaboration with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) for their precision medicine cancer trial, NCI-Molecular Analysis for Therapy Choice (NCI-MATCH or EAY131). This ongoing study is evaluating the benefit of genomically-guided treatments targeting specific alterations within a person’s tumor, regardless of cancer type. Foundation Medicine will notify physicians at the more than 1,100 clinical sites participating in NCI-MATCH when the comprehensive genomic profiling (CGP) assays they ordered to guide clinical care, FoundationOne® or FoundationOne® Heme, reveal findings that may make a patient eligible for one of several NCI-MATCH treatments.
The FoundationOne and FoundationOne Heme assays comprehensively interrogate hundreds of cancer-related genes in solid tumors, or hematologic cancers and advanced sarcomas, respectively, to identify genomic alterations that can help match a patient with a therapy that targets those alterations. Foundation Medicine and its CGP assays were selected for participation in NCI-MATCH based on the validation, reliability and accuracy of the assays, the ability to review a high volume of patient cases due to the mainstream use of FoundationOne and FoundationOne Heme in clinical care today, and the ability to provide assay results in a format that can be uploaded into MATCHbox, the trial’s informatics system that generates patient treatment assignment information for the trial’s panel of experts to review.
“The NCI-MATCH trial is vital to learning more about the genomic basis of cancer biology and the best ways to improve cancer treatment for each individual patient,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “We believe this innovative trial design leveraging genomics to inform potential treatment modalities will become the standard for oncology clinical studies, particularly to identify signals of effectiveness that can be studied in larger, more definitive trials. We believe our collaboration will help the clinical sites participating in the trial to identify a larger number of patients who may be eligible to enroll for treatment.”
Through this collaboration, Foundation Medicine will assist ECOG-ACRIN and the NCI in casting a wider net for patients that may be eligible for NCI-MATCH. Foundation Medicine will identify individuals whose tumors are profiled through standard clinical care with FoundationOne or FoundationOne Heme and are found to harbor genomic alterations being studied in NCI-MATCH, as determined by Foundation Medicine’s proprietary SmartTrials™ engine that allows for alteration-level specificity in matching patients to the trial. If the individual is identified at a site that is participating in the trial, Foundation Medicine’s SmartTrials outreach services will notify their treating physician that the patient may be eligible for enrollment into NCI-MATCH. The oncologist can take the information into consideration when discussing treatment options with his or her patients. Foundation Medicine initiated inclusion of NCI-MATCH in this outreach in May 2017.
About the NCI-MATCH Study
NCI-MATCH is a phase II precision
medicine trial that seeks to determine the effectiveness of treatment
that is directed by genomic profiling in patients with solid tumors,
lymphomas, or myelomas that have progressed following all standard
treatments expected to prolong overall survival or rare cancer types for
which there is no standard treatment. The study attempts to demonstrate
that matching certain drugs or drug combinations in adults whose tumors
have specific gene abnormalities will effectively treat cancer,
regardless of its type. Such discoveries could be eligible to move on to
larger, more definitive trials.
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. 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.
Cautionary Note Regarding Forward-Looking Statements for
Foundation Medicine
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
comprehensive genomic profiling, including FoundationOne and
FoundationOne Heme; the ability of CGP and the SmartTrials services to
identify a larger number of patients who may be eligible to enroll for
treatment in a clinical study; and the ability of a clinical trial,
including the clinical trial design, to 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; 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.
