Foundation Medicine & Its Collaborators to Present New Data at ASCO 2017 Supporting the Integration of Comprehensive Genomic ...
May 18 2017 - 7:00AM
Business Wire
--New data, including content from two oral
presentations continues to validate the clinical value of molecular
information from CGP in guiding treatment towards targeted therapy,
immunotherapy, and clinical trials--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that data
from its suite of comprehensive genomic profiling (CGP) assays,
including FoundationOne®, FoundationACT® liquid biopsy,
FoundationOne® Heme, and FoundationFocus™ CDxBRCA will be presented
during the American Society of Clinical Oncology (ASCO) Annual
Meeting from June 2-6, 2017 in Chicago. The company and its
collaborators will present a total of 33 studies at the meeting,
including two oral presentations, eight poster discussions and
twenty-three posters, ranging across 15 different tumor types. Data
demonstrate the impact of tissue- and blood-based CGP on guiding
targeted therapy, immunotherapy, or clinical trial decisions in
advanced cancers. In addition, the clinical value of CGP as
evidenced through real world evidence and outcomes research (HEOR)
studies, as well as data highlighting the ability of CGP to
accelerate clinical trial enrollment will be presented.
“Together these studies highlight the importance of our CGP
approach in advancing precision medicine in cancer care and build
upon the growing body of evidence supporting its use in clinical
practice,” said Vincent Miller, M.D., chief medical officer at
Foundation Medicine. “Previous findings from Foundation Medicine
have shown that measuring tumor mutational burden (TMB) with
FoundationOne can predict responses to FDA-approved
anti-PD-1/anti-PD-L1 immunotherapies across multiple tumor types.
New results will be presented at this year’s ASCO which help
describe the landscape of TMB in triple-negative breast cancer,
ovarian cancer, metastatic melanoma, biliary tract cancer and
cancer of unknown primary, pointing to potentially new subsets of
patients who may benefit from this therapeutic strategy. We believe
these data will be critical to advancing the field of
immunotherapy, and will be particularly insightful for clinicians,
as well as biopharma companies seeking to advance immunotherapeutic
agents. In addition, we’ll present exciting new data demonstrating
the impact of our decision support tools on accelerating clinical
trial enrollment - - helping to address an important need in cancer
care.”
New results include an oral presentation titled “Comprehensive
genomic profiling with loss of heterozygosity to identify
therapeutically relevant subsets of ovarian cancer,” which shows
that CGP can reveal molecular, rather than histologic, patient
subsets who may benefit from poly (ADP-ribose) polymerase (PARP)
inhibitor targeted therapy or immunotherapy. These results also
provide support for insurance coverage and further integration of
CGP into clinical trials in ovarian cancer.
Further supporting the integration of CGP at diagnosis, results
from health economic and outcomes studies will be presented,
demonstrating that early integration of CGP into a patient’s
clinical and diagnostic work-up leads to improved patient outcomes
associated with reasonable incremental costs to the payer that are
largely driven by increased survival time on treatment. One poster
titled “Estimated Cost of Anti-Cancer Therapy Directed by CGP in a
Single-Center Study” discusses estimated anti-cancer drug costs and
the associated cost impact of overall survival (OS) for matched vs.
unmatched therapy in patients enrolled in a previously reported
clinical trial using FoundationOne to guide therapeutic
decisions.
In addition, important new studies will be presented on the
ability of FoundationACT liquid biopsy assay to identify ESR1 and
PIK3CA mutations in metastatic breast cancer, acquired resistance
mutations in non-small cell lung cancer and BRCA1/2 reversion
mutations in prostate cancer, all of which could help guide
treatment decisions for these indications.
Other studies demonstrate the ability of CGP to accelerate
clinical trial enrollment. Results from “Accelerating clinical
trial enrollment with comprehensive genomic profiling (CGP) and
‘Just-in-Time’ clinical trial sites: An index case of a paradigm
shift”, reveal a new approach for matching patients to clinical
trials that focus on rare genomic findings. Combined with a
computational matching infrastructure, this approach could
accelerate drug development and improve access to novel targeted
therapies.
Following is a list of selected abstracts, including those
referenced above.
Visit http://info.foundationmedicine.com/annual-meeting-2017 for
a complete list of abstracts and to stay connected with Foundation
Medicine during the ASCO meeting.
Immunotherapy/TMB Data
- Oral Presentation:
Abstract 5512 - Comprehensive genomic profiling (CGP) with
loss of heterozygosity (LOH) to identify therapeutically relevant
subsets of ovarian cancer (OC), June 5, E450ab, 8:48am –
9:00am
- Abstract 9536 - Landscape of
genomic alterations (GA) and tumor mutational burden (TMB) in
different metastatic melanoma (MM) subtypes, June 3, Hall A, 1:15pm
– 4:45pm
- Abstract 4086 - Tumor mutational
burden (TMB) and co-existing actionable mutations in biliary tract
cancers (BTC), June 3, Hall A, 8:00am – 11:30am
- Abstract 3039 - Mutational
burden of tumors with primary site unknown, June 5, Hall A, 8:00 am
– 11:30am
- Abstract 9072 - BRAF fusions in
clinically advanced non-small cell lung cancer: An emerging target
for anti-BRAF therapies, June 3, Hall A, 8:00am – 11:30am
Targeted Therapy Data
- Oral Presentation:
Abstract 11001 - Impact of next-generation sequencing
(NGS) on diagnostic and therapeutic options in soft-tissue and bone
sarcoma, June 2, S100bc, 3:12pm – 3:24pm
- Abstract 3583 - Targeted therapy
for HER2 driven colorectal cancer, June 3, Hall A, 8:00am –
11:30am
Health Economic Data
- Abstract 6599 – Comprehensive
genomic profiling (CGP) versus conventional molecular diagnostic
testing of patients with advanced non-small cell lung cancer
(NSCLC): Overall survival (OS) and cost in US health plan
population, June 5, Hall A, 1:15pm – 4:45pm
- Abstract 6605 – Estimated cost
of anti-cancer therapy directed by comprehensive genomic profiling
(CGP) in a single-center study, June 5, Hall A, 1:15pm –
4:45pm
Liquid Biopsy Data
- Abstract 1016 - Genomic
profiling of circulating tumor DNA (ctDNA) from patients (pts) with
metastatic breast cancer (mBC), June 4, Hall B1, 4:45pm –
6:00pm
- Abstract 9025 - Genomic
profiling of circulating tumor DNA (ctDNA) from patients (pts) with
advanced non-small cell lung cancer (NSCLC), June 3, Hall A, 8:00am
- 11:30am
- Abstract 5024 - BRCA1/2
reversion mutations in prostate cancer identified from clinical
tissue and liquid biopsy samples, June 5, Hall A, 1:15pm -
4:45pm
- Abstract 4128 - Genomic
profiling of circulating tumor DNA (ctDNA) from patients (pts) with
pancreatic ductal adenocarcinoma (PDA), June 3, Hall A, 8:00am –
11:30am
Clinical Trial and Partnerships Data
- Abstract 6539 - Accelerating
clinical trial enrollment with comprehensive genomic profiling
(CGP) and just-in-time clinical trial sites: An index case of a
paradigm shift, June 5, Hall A, 1:15pm – 4:45pm
- Abstract 2512 - Personalized,
molecularly matched combination therapies for treatment-naïve,
lethal malignancies: The I-PREDICT study, June 5, Arie Crown
Theater, 11:30am – 12:45pm
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®, FoundationOne® and FoundationACT® are
registered trademarks and FoundationFocus™ 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 the value
of comprehensive genomic profiling, including FoundationOne,
FoundationOne Heme, FoundationACT and FoundationFocus, and
molecular information from CGP, in cancer care, acceleration of
clinical trial enrollment, and the development of targeted
therapies; the ability of TMB to predict responses to certain types
of FDA-approved therapies; and the ability of CGP to improve
patient outcomes associated with reasonable incremental costs to
the payer. 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 the results presented are found
to lack scientific, medical or clinical utility or that subsequent
research renders the results presented less useful or not useful in
clinical practice; Foundation Medicine's services and
molecular information platform 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, 2016, 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.
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Foundation Medicine, Inc.Media:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestors:Kimberly
Brown, 617-418-2215ir@foundationmedicine.com
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