CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Medicine, Inc. (NASDAQ:FMI) today announced that the discovery of a
novel and potentially clinically actionable oncogenic gene fusion in
lung cancer, NTRK1, using FoundationOne™, was published in the
current online edition of Nature Medicine1.
Lung cancer remains the leading cause of cancer-related death in men and
women in the United States2; however, the use of targeted
therapies in lung cancer has led to significant clinical benefit for
patients with EGFR mutations and ALK fusions. Therefore,
the identification of new, drug-sensitive oncogenes in this disease is
of great clinical interest and has the potential to expand treatment
options for patients.
"Our understanding of cancer complexity is increasing, and lung cancer
continues to be dissected into a series of uncommon or even rare
diseases based on the molecular alterations driving a patient's
individual cancer," stated Vincent Miller, M.D., chief medical officer
at Foundation Medicine and co-author of the study. "By discovering a new
and potentially clinically actionable gene fusion in lung cancer, we
believe this is an opportunity to explore new and different treatment
options for patients harboring this fusion. Based on these findings, we
believe clinical studies of selective TRK inhibitors in NTRK1
rearranged non-small cell lung cancer are warranted."
Michael J. Pellini, M.D., president and chief executive officer at
Foundation Medicine added, "In addition to making important
contributions to cancer patient care, the discovery of novel gene
markers using FoundationOne is an excellent example of how clinical and
commercial progress can coincide, especially in collaboration with
academic investigators. These discoveries drive the evolution of
FoundationOne, support new and ongoing collaborations with our pharma
partners, and provide further evidence that our comprehensive approach
yields high clinical utility."
In an effort to identify additional potential oncogenes in lung cancer,
Foundation Medicine and its collaborators, the University of Colorado
Cancer Center and Dana-Farber Cancer Institute, used FoundationOne to
assess cancer-related genes on tumor samples from 36 patients negative
for activating alterations in EGFR, KRAS, ALK, and ROS1
using standard clinical assays. Researchers identified novel gene
fusions harboring the kinase domain of the NTRK1 gene that
encodes the TRKA receptor. Both the MPRIP-NTRK1 and CD74-NTRK1
fusions demonstrated constitutive TRKA kinase activity. Preclinical data
show that treatment of cells expressing NTRK1 fusions with
inhibitors of TRKA kinase activity (ARRY-470, CEP-701, and crizotinib)
inhibited tumor growth. In the study, one patient harboring the MPRIP-NTRK1
fusion demonstrated a minor radiographic response to crizotinib. Three
of 91 patients (3.3%) without known oncogenic alterations profiled by
FoundationOne harbored an NTRK1 gene fusion. These results
suggest that NTRK1 gene fusions are a new oncogenic alteration in
lung cancer and TRK inhibitors should be evaluated in clinical trials in
patients harboring this gene fusion.
"Following the recent publication of our analytic validation study of
FoundationOne, the identification of NTRK1 further supports the
clinical utility of comprehensive next-generation sequencing as a method
to discover novel drug sensitive genomic alterations that would not
otherwise be tested for or identified using currently available
diagnostic approaches," commented Phil Stephens, Ph.D., vice president,
cancer genomics at Foundation Medicine. "Additionally, the preclinical
data and preliminary clinical data on patient response to TRK inhibitor
therapy informed by FoundationOne are very encouraging for further
clinical investigation of TRK inhibitors in this patient population."
Foundation Medicine last week announced that results from a 24-month,
multi-institution collaboration demonstrating the analytic validation of
its cancer genomic profiling assay, FoundationOne™, were published in
the online edition of Nature Biotechnology3.
This publication is the first to apply and extend the guidelines
established by the Next-Generation Sequencing: Standardization of
Clinical Testing (Nex-StoCT) workgroup to validate a clinical
sequencing-based assay for cancer, therefore setting the standard for
validation of targeted NGS in cancer.
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's initial
clinical assay, FoundationOne™,
is a fully informative genomic profile to identify a patient's
individual molecular alterations and match them with relevant targeted
therapies 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
Foundation Medicine® is a registered
trademark, and FoundationOne™ is a trademark of
Foundation Medicine, 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 new and potentially
clinically actionable gene fusions, the development of new treatment
options for patients with certain gene fusions, the evolution of
FoundationOneTM, and the clinical utility of
FoundationOneTM and next-generation sequencing
as a method to discover novel drug sensitive genomic alterations. 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
FoundationOneTM and any subsequent products may
never achieve significant commercial adoption or reimbursement support;
Foundation Medicine is unable to achieve profitability, to compete
successfully, to manage its growth, or to develop its molecular
information platform; and the risks described under the caption "Risk
Factors" in Foundation Medicine's Registration Statement on Form S-1
(File No. 333-190226), 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.
1. Vaishnavi, A. et al. Oncogenic and drug sensitive NTRK1
rearrangements in lung cancer. Nature Medicine, 2013. DOI:
2. American Cancer Society. Cancer Facts & Figures 2012.
3. Frampton, G.M. et al. Validation and clinical application of a cancer
genomic profiling test using next-generation sequencing. Nature
Biotechnology, 2013; DOI: 10.1038/NBT.2696.
Pure Communications, Inc.
Source: Foundation Medicine, Inc.
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