Foundation
Medicine, Inc. (NASDAQ:FMI) today announced new data further
demonstrating the clinical utility of FoundationOne®
across several types of breast cancer, including metastatic and
inflammatory breast cancer. Collectively, these studies support the use
of comprehensive genomic profiling to identify distinct genomic
alterations that may further tailor treatment options and result in
improved outcomes for patients with breast cancer. These data are being
presented by Foundation Medicine and its collaborators during the 2014
San Antonio Breast Cancer Symposium.
Breast cancer is the most common type of cancer among women in the
United States, excluding cancers of the skin. The American Cancer
Society estimates that approximately 233,000 women will be diagnosed
with breast cancer in 2014, accounting for approximately 29 percent of
all newly diagnosed cancers. The risk of breast cancer increases with
age, and inherited genomic alterations or a family history also
predispose patients to this malignancy.
FoundationOne, the company’s flagship clinical test for patients with
solid tumors, is a comprehensive genomic profile that identifies the
genomic alterations in a patient’s unique cancer and matches them with
relevant targeted therapies and clinical trials. The test also
contributes to a large and growing database of molecular information
that can be leveraged to gain new insights into the biology and
treatment of breast cancer and other solid tumors.
“Breast cancer is increasingly considered to be not one disease, but a
group of diseases distinguished by different molecular subtypes, risk
factors, clinical behaviors and responses to treatment,” said Vincent
Miller, M.D., chief medical officer, Foundation Medicine. “As such, we
believe there is high value in utilizing a comprehensive genomic
profiling approach in order to inform potential treatment options that
may improve outcomes for breast cancer patients. We are pleased to share
these data from real-world, clinical settings that further support the
value and actionability of FoundationOne in this important patient
population.”
Key Poster Data:
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“Incidence of actionable genomic alterations in metastatic breast
cancer: A prospective study” (P2-03-03), assesses the feasibility
and impact of FoundationOne genomic profiling among patients with
advanced breast cancer. In this prospective, ongoing single-arm trial
conducted at The Ohio State University Comprehensive Cancer Center, 40
patients were tested with FoundationOne. Across the 37 cases reported
to date, a total of 192 genomic alterations were detected, with a
median of five alterations per patient. Among all patients who
received a report, 97% were matched with at least one potential
FDA-approved treatment or clinical trial. Specifically, investigators
matched 65% of patients (n=24) with an FDA-approved breast cancer
therapy. The report also matched 24 patients (65%) with an
FDA-approved therapy for an indication other than breast cancer based
on their specific genomic alteration. Nearly all patients were
suggested at least one potential clinical trial. These findings
demonstrate that FoundationOne was successful in identifying
clinically relevant genomic alterations in the majority of women with
advanced breast cancer who participated in the trial.
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“Activating mutations in ERBB2/HER2 as found by FoundationOne®
represent potential therapeutic targets in breast cancer”
(P4-15-03), describes the use of FoundationOne in 7,300 patients with
solid tumors, including a large number of breast cancer patients, to
determine how many of these patients could benefit from HER2-targeted
therapy due to activating mutations in ERBB2, and how
widespread these alterations are across the solid tumor spectrum.
Comprehensive genomic profiling using FoundationOne, as compared to
conventional diagnostic testing which uses IHC or FISH to detect only
ERBB2 amplifications, resulted in the identification of 25% more
breast cancers that may be amenable to HER2 targeted therapy due to
the presence of activating mutations in ERBB2. Known
oncogenic ERBB2 alterations were identified in approximately 6%
of all solid tumors across 27 different histologies. Of all the ERBB2
alterations, activating mutations in ERBB2 were identified in
131 samples and amplifications were observed in 246 samples. These
data highlight the potential clinical implications of comprehensive
genomic profiling to test for both activating ERBB2 mutations
and amplifications, and suggest that the current approach of testing
only breast and gastric tumors for HER2 amplifications is potentially
limiting the application of ERBB2/HER2 targeted therapeutics.
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“Genomic profiling by FoundationOne® analysis of
inflammatory breast cancer cases reveals a high frequency of
clinically relevant genomic alterations (GA)” (P6-14-02),
demonstrates the potential clinical impact of comprehensive genomic
profiling on patients with inflammatory breast cancer (IBC), a rare
and aggressive form of breast cancer with limited treatment options
and which is commonly associated with a particularly poor prognosis.
In 55 patients with IBC whose tumors were analyzed using
FoundationOne, a total of 274 genomic alterations were detected with
an average of five alterations per tumor. Among these patients, 96%
(n=53) had at least one alteration that suggested a potential
responsiveness to therapies that are FDA approved or being studied in
clinical trials. Of these, two patients were directed to targeted
therapy that led to positive clinical outcomes after FoundationOne
uncovered their unique and unanticipated alterations. These data
support the use of FoundationOne to identify potential new treatment
options in patients with metastatic IBC.
About FoundationOne®
FoundationOne, the company's first clinical product, is a fully
informative genomic profile for solid tumors used by oncologists to
identify the molecular alterations in a patient's tumor and match those
alterations with relevant targeted therapies and clinical trials. Using
next-generation sequencing in routine cancer specimens, FoundationOne
interrogates all genes somatically altered in human cancers that are
validated targets for therapy or unambiguous drivers of oncogenesis
based on current knowledge. It reveals all classes of genomic
alterations including base substitutions, insertions, deletions, copy
number alterations and select rearrangements. FoundationOne fits easily
into the clinical workflow of the ordering physician, and test results
are provided in an easy-to-interpret report supported by a comprehensive
review of published literature. FoundationOne is a laboratory-developed
test performed at Foundation Medicine's CLIA-certified lab. The test is
accredited by CAP, is approved by the New York State Department of
Health and has received a CE Mark. Please visit www.FoundationOne.com for
more information.
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 clinical assays,
FoundationOne for solid tumors and FoundationOne Heme for hematologic
malignancies, sarcomas and pediatric cancers, provide a fully
informative genomic profile to identify the molecular alterations in a
patient’s cancer 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 (@FoundationATCG).
Foundation Medicine® and FoundationOne®
are registered trademarks 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 clinical utility
of FoundationOne, including for patients with breast cancer; the ability
of FoundationOne or comprehensive genomic profiling to identify genomic
alterations that inform treatment options or result in improved outcomes
for cancer patients; and the ability of FoundationOne to predict which
patients would benefit from certain targeted therapies or new treatment
options. 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 FoundationOne will not be able to
identify genomic alterations in the same manner as prior clinical data,
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,
2013, which is on file with the Securities and Exchange Commission, as
well as other risks detailed in subsequent filings with the Securities
and Exchange Commission, may be realized. 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.
Copyright Business Wire 2014