CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Medicine, Inc. (NASDAQ:FMI) today announced the discovery of a high
incidence of ERBB2 (HER2) extracellular domain alterations
in patients with micropapillary urothelial carcinoma (MPUC), a
particularly aggressive form of urinary bladder cancer, using
FoundationOne™. The research was published in the current edition of Clinical
"This study identifies a recurrent clinically actionable2
genomic alteration in an extremely aggressive subtype of urinary bladder
cancer and opens the door for the use of targeted therapies to treat a
significant proportion of patients with this disease," said Jeffrey S.
Ross, M.D., medical director, Foundation Medicine and co-lead author of
the study. "By using FoundationOne, a highly sensitive, fully
informative genomic profile, we were able to identify an alteration that
is not typically tested for in the routine care of these patients. We
believe this discovery may enable new opportunities for treating
patients with this rapidly progressive form of cancer with anti-ERBB2
In this study, Foundation Medicine researchers conducted comprehensive
genomic profiling using FoundationOne on 15 MPUC and 64
non-micropapillary urothelial bladder carcinomas (non-MPUC) FFPE tumor
samples. Mutations in the extracellular domain of ERBB2 were
identified in six of 15 (40%) MPUC samples. All six cases of MPUC with
an ERBB2 mutation were negative for ERBB2 amplification
and ERBB2 overexpression. In contrast, six of 64 (9.4%) non-MPUC
samples harbored an ERBB2 alteration, including base
substitutions (three cases), amplifications (two cases), and gene fusion
(one case), which is higher than the two of 159 (1.3%) protein-changing ERBB2
alterations reported for urinary bladder cancer in COSMIC. The
enrichment of ERBB2 alterations in MPUC compared with non-MPUC is
statistically significant both between this series (P < 0.0084)
and for all types of urinary bladder cancer in COSMIC (P < 0.001).
MPUC is an uncommon subtype of urothelial carcinoma with an incidence of
3,000 to 4,000 cases per year in the United States.
About Foundation Medicine
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 clinical
for solid tumors and FoundationOneTM
Heme for hematologic malignancies, sarcomas and pediatric cancers, each
provide 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 FoundationOneTM
is a trademark, of Foundation Medicine, Inc.
Cautionary Notes 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 anticipated
recurrence of a clinically actionable genomic alteration in patients
with a form of micropapillary urinary bladder cancer, the ability of
Foundation Medicine's genomic profile to identify this genomic
alteration, the use of targeted therapies to treat patients with this
form of urinary bladder cancer, and the enablement of new opportunities
for treating patients with this form of urinary bladder cancer. 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 genomic profile may not properly or fully identify
the relevant genomic alteration; targeted therapies to treat such
patients may not be available or may not be responsive to patients with
this disease; and the risks described under the caption "Risk Factors"
in Foundation Medicine's Form 10-Q, 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. Ross, J. and Wang, K. et al. A High Frequency of Activating
Extracellular Domain ERBB2 (HER2) Mutation in Micropapillary Urothelial
Carcinoma. Clin Cancer Res; 20(1); 68—75.
2. Alterations are defined as clinically actionable if linked to an FDA
approved targeted therapy in the tumor under study or to another tumor
type, or to an open clinical trial targeting a relevant pathway.
Pure Communications, Inc.
Source: Foundation Medicine, Inc.
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