--Data to be Presented at the 2018 Annual
Meeting of the American Association for Cancer Research--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced the
presentation of new findings at the American Association for Cancer
Research (AACR) Annual Meeting. The data supports the use of both
tissue- and blood-based comprehensive genomic profiling (CGP) to
advance personalized cancer care and inform the use of targeted and
immunotherapy treatment approaches. Presentations span several of
Foundation Medicine’s suite of molecular information products
including its recently FDA approved assay, FoundationOne CDx™, as
well as FoundationOne®, FoundationACT® and the company’s novel
blood-based assay to measure tumor mutational burden (bTMB).
The AACR Annual Meeting will be held April 14-18, 2018 at
McCormick Place in Chicago, Illinois.
“Personalized oncology care is rapidly evolving, underscoring
the need for the identification of new biomarkers that may help
predict response to treatment and improve access to, and success
of, targeted therapeutic trials in oncology,” said Vincent Miller,
M.D., chief medical officer at Foundation Medicine. “As such, we
are excited to present new data generated from the use of our suite
of CGP tests at this year’s AACR meeting that advance both of these
goals. These data identify novel genomic biomarkers of response to
important new treatment options using either a tissue sample or a
blood sample across a diverse range of tumor types, helping to
demonstrate the broad impact CGP can have on advancing cancer
care.”
In the area of immunotherapy, new data will be presented
highlighting the use of Foundation Medicine’s bTMB assay, which is
currently being utilized in a global clinical trial setting to
investigate bTMB as a non-invasive biomarker of response to
first-line atezolizumab in advanced non-small cell lung cancer
(NSCLC) patients as part of Roche/Genentech’s prospective,
randomized Phase III Blood
First Assay Screening
Trial (BFAST). Previously this assay
was shown to be associated with response to the anti-PD-L1
immunotherapy agent, atezolizumab, in individuals with
previously-treated NSCLC. New data to be presented at AACR builds
on these findings, showing that: (a) high TMB is significantly
associated with improved survival on atezolizumab versus
chemotherapy in second-line NSCLC, (b) measurement of high TMB
using Foundation Medicine’s assays in blood versus tissue is
correlated with, and is largely explained by, shared variants
present in both sample types, and (c) a sufficiently-sized assay is
required to reliably characterize patients with high TMB.
Additional findings to be presented may help further guide the
use of checkpoint inhibitor cancer immunotherapy. For example, one
study found that tumor mutational burden (TMB), which has been
shown to predict response to immunotherapy in many cancer types,
varied between patients of different ancestries, suggesting that
the likelihood of benefit from immunotherapy may differ in these
patients as well. Another study, performed on the largest sequenced
cohort of Merkel cell carcinoma to date, identified TMB-high and
TMB-low subsets linked to distinct disease etiologies, providing
evidence that TMB and or presence of the etiologic virus may help
guide therapy in these patients.
Data generated utilizing the FoundationACT liquid biopsy assay
will be presented, which supports its potential utility in
predicting clinical outcomes. An oral presentation will highlight a
retrospective analysis utilizing FoundationACT, as well as a custom
liquid biopsy assay, to measure circulating tumor DNA (ctDNA) from
a Phase II study of metastatic triple-negative breast cancer
(mTNBC), showing that on-treatment quantitative changes in genomic
alterations were associated with clinical outcomes to a targeted
therapy/chemotherapy treatment combination.
Clinical validation data for FoundationOne CDx will also be
presented, demonstrating high concordance with multiple
FDA-approved companion diagnostics, as well as other assays,
including another CLIA-validated next generation sequencing assay
and other single marker assays, currently used to identify targeted
therapies in patients with NSCLC, melanoma, colorectal cancer,
ovarian cancer, and breast cancer.
Other studies include those that identify novel biomarkers of
targeted therapy treatment response, such as novel PTEN alterations
in metastatic triple negative breast cancer (mTNBC), or genomic
loss of heterozygosity in non-BRCA positive ovarian cancer
patients. Such findings could be used to broaden intent-to-treat
populations in clinical trials and identify larger patient
populations that may respond to approved treatments.
Following is a list of abstracts that will be presented at the
meeting.
Presentation #
Title
Day/Time
Location
Immunotherapy/TMB
PO.EP01.04
Somatic genome alterations in cancer as
compared to inferred patient ancestry
April 16;8:00am-12:00pm
Poster Section 10
CTPL03-CT077 (Oral
Presentation)
Nivolumab (nivo) + ipilimumab (ipi) vs
platinum-doublet chemotherapy (PT-DC) as first-line (1L) treatment
(tx) for advanced non-small cell lung cancer (NSCLC): initial
results from CheckMate 227
April 16;11:35am-11:55am
N Hall B
CTPL03-CT078
(Oral Presentation)
Tumor mutational burden (TMB) as a biomarker
for clinical benefit from dual immune checkpoint blockade with
nivolumab (nivo) + ipilimumab (ipi) in first-line (1L) non-small
cell lung cancer (NSCLC): identification of TMB cutoff from
CheckMate 568
April 16;
12:05pm-12:25pm
N Hall B
PO.TB11.02
Comprehensive genomic profiling of Merkel cell
carcinoma samples reveals bimodal distribution of tumor mutational
burden and two mutually exclusive candidate mechanisms of
carcinogenesis
April 17;1:00pm-5:00pm
Poster Section 1
PO.IM02.04
A Blood Based Next Generation Sequencing Assay
to Determine Tumor Mutational Burden (bTMB) Is Associated with
Benefit to an Anti-PD-L1 Inhibitor, Atezolizumab
April 18;8:00am-12:00pm
Poster Section 32
Liquid Biopsy & Targeted
Therapy
PO.ET04.05
Identification of potential resistance
mechanisms to EGFR treatment in the real world using a
clinicogenomic database
April 16;8:00am-12:00pm
Poster Section 36
MS.CL10.02 (Oral Presentation)
On-treatment changes in circulating tumor DNA
(ctDNA) level as an early predictor of clinical outcome in the
LOTUS randomized phase II trial of first-line ipatasertib (IPAT)
plus paclitaxel (PAC) for metastatic triple-negative breast cancer
(mTNBC)
April 16;4:35pm-4:50pm
Room S406
PO.CL10.02
A novel PI3K/Akt-pathway activation biomarker
using comprehensive genomic profiling (CGP) for clinical trial
assay
April 16;1:00pm-5:00pm
Poster Section 25
PO.MCB09.03
Novel CDH1 mutations in breast invasive
lobular carcinoma
April 16;1:00pm-5:00pm
Poster Section 16
PO.CL10.06
A validated diagnostic assay for identifying
patients with ovarian cancer with high genomic loss of
heterozygosity (LOH) without deleterious BRCA mutations
April 17;1:00pm-5:00pm
Poster Section 24
FoundationOne CDx
PO.MCB09.02
Comparative analysis of clinically validated
NGS-based assays reveals high concordance across short variants
April 15;1:00pm-5:00pm
Poster Section 19
PO.CL01.03
An ERBB2 follow-on companion diagnostic for
clinical care of patients with breast cancer
April 16;8:00am-12:00pm
Poster Section 27
PO.SHP01.01
A clinically-validated comprehensive companion
diagnostic platform for care of patients with advanced cancer
April 17;1:00pm-5:00pm
Poster Section 35
About Foundation MedicineFoundation 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 FoundationOne CDx™ is a trademark of
Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for
Foundation MedicineThis 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 and impact of CGP, including FoundationOne,
FoundationACT and FoundationOne CDx, and molecular information from
CGP, in cancer care, predicting response to treatment, and
improving access to and success of targeted trials in oncology; and
the ability of tissue and blood based TMB to predict responses to
certain types of cancer, including NSCLC. 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
assays 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, 2017, 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 Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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