-- Pan-Cancer MSI Companion Diagnostic for KEYTRUDA® (pembrolizumab) Planned for Inclusion on FoundationOne CDx™--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced a collaboration with Merck, known as MSD outside the United States and Canada, to develop companion diagnostic tests for use with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability (MSI) high or mismatch repair deficient solid tumors. The companion diagnostic tests will leverage FoundationOne CDx™, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics. The companies will collaborate on the development of a pan-cancer companion diagnostic to measure MSI. In addition, they plan to develop companion diagnostics for tumor mutational burden (TMB), as well as additional potential novel biomarkers of response.
“By collaborating, Merck and Foundation Medicine can continue to push the frontier on innovation in immuno-oncology and personalized cancer care, making a positive difference in the lives of individuals with cancer,” said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. “The addition of MSI and TMB companion diagnostics to FoundationOne CDx re-affirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule-in and rule-out potential treatment options based on each patient’s genomic and biomarker status, and can help accelerate patient access to personalized healthcare.”
“Rapidly evolving knowledge of cancer biology and immuno-oncology continues to improve understanding of how to deploy our medicines to identify those patients most likely to respond effectively,” said Dr. Eric Rubin senior vice president oncology clinical development, Merck Research Laboratories. “We look forward to working with Foundation Medicine on this companion diagnostics strategy.”
FoundationOne CDx, an FDA-approved CGP assay for all solid tumors, assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment options. FoundationOne CDx is also FDA-approved as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, 12 of which are approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as MSI and TMB, that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information. In all of these ways, FoundationOne CDx is available to biopharma companies as an FDA-approved platform for clinical research and as a CGP platform for biopharma companies seeking to develop companion diagnostics for their precision therapeutics.
FoundationOne CDx is available to order online at www.foundationmedicine.com/genomic-testing/order, or visit https://home.foundationmedicine.com/signup to sign up for an account.
About FoundationOne CDx
FoundationOne CDx is a
next-generation sequencing based in vitro diagnostic device for
detection of substitutions, insertion and deletion alterations (indels),
and copy number alterations (CNAs) in 324 genes and select gene
rearrangements, as well as genomic signatures including microsatellite
instability (MSI) and tumor mutational burden (TMB) using DNA isolated
from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
FoundationOne CDx is intended as a companion diagnostic to identify
patients who may benefit from treatment with certain targeted therapies
in accordance with their approved therapeutic product labeling.
Additionally, FoundationOne CDx is intended to provide tumor mutation
profiling to be used by qualified health care professionals in
accordance with professional guidelines in oncology for patients with
solid malignant neoplasms. For a full list of targeted therapies for
which FoundationOne CDx is indicated as a companion diagnostic, please
visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
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® is a registered trademark and FoundationOne CDx™ 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
a collaboration between Merck and Foundation Medicine; the ability of
FoundationOne CDx to measure TMB and MSI; the ability of FoundationOne
CDx to accelerate patient access to personalized healthcare; and the
timing or scope of any development or FDA approval of TMB or MSI
companion diagnostics for inclusion on FoundationOne CDx. 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 risks that the
collaboration does not proceed as expected or does not meet the
objectives of the parties; FoundationOne CDx is not an effective
diagnostic test for measuring TMB or MSI; a delay on the part of, or
failure of, the parties to develop or the FDA to approve, any MSI or TMB
companion diagnostics; 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, 2017, 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.
View source version on businesswire.com:
Foundation Medicine, Inc.
Media:
Lee-Ann Murphy,
617-245-3077
pr@foundationmedicine.com
or
Investor:
Kimberly
Brown, 617-418-2215
ir@foundationmedicine.com