Foundation
Medicine, Inc. (NASDAQ:FMI) today announced new data demonstrating
that FoundationOne® Heme, developed in collaboration with Memorial Sloan
Kettering Cancer Center, provides critical genomic information that can
impact prognosis, influence therapeutic strategy and even refine
conventional pathologic diagnosis in patients with a wide range of
hematologic malignancies. Collectively, these data highlight the
potentially transformative impact of FoundationOne Heme across all
aspects of cancer care. These findings were presented in two posters and
an oral presentation at the American Society of Hematology Annual
Meeting in San Francisco.
“We are pleased to see the presentation of these data, which support the
utility of FoundationOne Heme as a valuable testing platform for
patients with a broad range of hematologic cancers,” said Vincent
Miller, M.D., chief medical officer, Foundation Medicine. “Through
FoundationOne Heme, our goal is to provide a physician with all of the
relevant genomic information needed to make a more precise and informed
treatment decision for their patients, which may include targeted
therapies or clinical trials. We believe this approach represents the
future of cancer care and are proud to be collaborating with Memorial
Sloan Kettering to help transform routine clinical practice through
comprehensive genomic profiling.”
FoundationOne Heme is a comprehensive genomic profile that analyzes DNA
of 405 genes and RNA of 265 genes that are most commonly altered in
hematologic malignancies and sarcomas. The test was commercially
launched in 2013, and is designed to provide physicians with clinically
actionable information to guide treatment options for patients based on
the genomic profile of their cancer.
“Genomic profiling has long been a critical part of the diagnostic
workup across all hematologic malignancies, yet it is often necessary to
perform multiple molecular, cytogenetic and hot-spot tests, an often
overwhelming process that makes it especially difficult to interpret
results and make therapeutic decisions based on the data,” added Marcel
van den Brink, M.D., Ph.D., Head, Division of Hematologic Oncology, Memorial
Sloan Kettering Cancer Center. “FoundationOne Heme is a single,
comprehensive assay that detects all classes of actionable genomic
alterations in cancer-driving genes, including fusions that are commonly
tested for in hematologic malignancies utilizing other technologies,
providing physicians with critical, easy-to-understand information that
may ultimately lead to improved outcomes for patients.”
Summary of Data Presentations:
-
“Genomic Profiling Combining DNA and RNA Analysis of 112
Formalin-Fixed Paraffin-Embedded Diffuse Large B Cell Lymphoma
Specimens Identifies a High Frequency of Clinically Relevant Genomic
Alterations” (abstract number 704), an oral presentation, provides
strong support for the utility of comprehensive genomic profiling to
identify clinically relevant genomic alterations in a common type of
lymphoma. In this study, 112 patients with diffuse large B cell
lymphoma (DLBCL) were tested with FoundationOne Heme, and 96% were
identified as having genomic alterations with diagnostic, prognostic
or therapeutic relevance. These findings suggest that FoundationOne
Heme’s streamlined approach has the potential to replace multiple
molecular and cytogenetic tests by combining them into a single,
comprehensive platform that can be used across a wide spectrum of
hematologic malignancies.
-
“A Comprehensive Clinical Next Generation Sequencing-Based Assay
Can Impact Hematopathologic Diagnosis in a Significant Subset of
Patients with Hematologic Malignancies” (abstract number 2984), a
poster, highlights the impact of FoundationOne Heme on pathologic
assessment and diagnosis across a wide spectrum of hematologic
malignancies, with the potential to augment or even replace
conventional diagnostic tests commonly used in these diseases. In this
study, 42 of 84 patients diagnosed with a hematologic malignancy (50%)
were identified by FoundationOne Heme as having genomic alterations
with diagnostic relevance. Importantly, in 14% of these cases (n=12),
the identified alterations led to a change or refinement of the
original diagnosis. Additionally, FoundationOne Heme identified
genomic alterations with prognostic relevance in 64% of patients
(n=54) and with potential therapeutic impact in 76% of patients
(n=64). These data support the use of FoundationOne Heme as a
first-line testing platform in a wide spectrum of hematologic
malignancies, not only for identifying prognostic and therapeutic
targets, but also for refinement of the underlying diagnosis.
-
“Clinical Utility of Comprehensive Profiling of Genomic Alterations
in Hematologic Malignancies,” (abstract number 1072), a poster,
demonstrates the ability of FoundationOne Heme to identify clinically
relevant genomic alterations in a vast majority of patients across a
broad range of hematologic malignancies. In this study, 705 of 746
patients (95%) who successfully underwent testing with FoundationOne
Heme were identified as having at least one somatic-driver genomic
mutation. Importantly, 68% of these patients (n=479) harbored at least
one potentially actionable alteration linked to a targeted therapy or
active clinical trial and 64% (n=451) had at least one alteration with
prognostic relevance. Furthermore, genomic rearrangements were
detected in tumors of 280 of 746 patients (n=38%), including novel
rearrangements involving known oncogenes and tumor suppressor genes.
About FoundationOne® Heme
FoundationOne Heme is a fully informative genomic profile for
hematologic cancers (leukemia, lymphoma and myeloma), as well as many
sarcomas and pediatric cancers, designed to provide physicians with
clinically actionable information to guide treatment options for
patients based on the genomic profile of their cancer. It is Foundation
Medicine's second commercially available targeted sequencing assay and
was developed in collaboration with Memorial Sloan Kettering Cancer
Center. Using next-generation sequencing in routine cancer specimens,
FoundationOne Heme interrogates all genes somatically altered in these
cancers that are validated targets for therapy or unambiguous drivers of
oncogenesis based on current knowledge. The test employs RNA sequencing
in addition to DNA sequencing to simultaneously detect all classes of
genomic alterations, including base pair substitutions, insertions and
deletions, copy number alterations and rearrangements, and gene fusions
(a type of alteration that is a common driver of hematologic
malignancies, sarcomas and pediatric cancers). FoundationOne Heme 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 Heme is a
laboratory-developed test performed at Foundation Medicine's
CLIA-certified lab. 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 http://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 Heme; the ability of FoundationOne Heme to affect the
prognosis, treatment or diagnosis of cancer patients; and the ability of
FoundationOne Heme to predict which patients would benefit from certain
commercially available therapies or clinical trials. 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 Heme 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