Foundation Medicine to Present Validation Data for Its Assay Measuring Tumor Mutational Burden in Blood (bTMB), a New, Non-In...
September 08 2017 - 7:00AM
Business Wire
--Data Supports Inclusion of the bTMB Assay
into a Phase III Clinical Trial of Atezolizumab Immunotherapy in
Individuals with Advanced Lung Cancer--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced
presentations at the European Society for Medical Oncology (ESMO)
Annual Meeting highlighting validation data for its novel assay to
measure tumor mutational burden from blood (bTMB). These
presentations will highlight retrospective data analysis from
Roche/Genentech’s Phase II POPLAR and Phase III OAK studies that
enabled analytic and clinical validation for the bTMB assay. The
studies demonstrate that high bTMB as measured by Foundation
Medicine’s assay is associated with response to atezolizumab in
individuals with previously-treated non-small cell lung cancer
(NSCLC), potentially offering a new option to expand personalized
care options for patients with advanced cancer.
Based on these findings, Foundation Medicine also announced
today that its bTMB assay will be integrated as part of
Roche/Genentech’s prospective, randomized Phase III Blood First
Assay Screening Trial (BFAST) as a companion diagnostic assay to
investigate bTMB as a non-invasive biomarker of response to
first-line atezolizumab in advanced NSCLC patients.
“Foundation Medicine has previously shown that measuring tumor
mutational burden from tissue samples can help reliably predict
responses to immunotherapies. However, a critical need exists for
measuring TMB via a non-invasive solution for cancer patients for
whom tissue is not available or when a biopsy is not feasible,”
said Vincent Miller, M.D., chief medical officer at Foundation
Medicine. “Our data at ESMO provide the first evidence that
response to immunotherapy can be predicted using only a blood
sample and we’re pleased that we recently received FDA clinical
trial approval for the Phase III study to validate bTMB as a
biomarker in first-line immunotherapy. Based on the study results,
we expect further development of our bTMB assay as a companion
diagnostic, providing an important predictive and complementary
solution to FoundationACT® liquid biopsy, and ultimately enabling
physicians to make informed selection of targeted or immunotherapy
treatments in the absence of tissue.”
In the studies presented at ESMO, Foundation Medicine’s bTMB
assay was analytically validated to determine TMB with high
precision and accuracy from as little as one percent tumor content
in a blood sample. The assay was used to retrospectively analyze a
total of 794 plasma samples from the Phase II POPLAR and Phase III
OAK clinical trials. The analysis showed that atezolizumab
demonstrated a clear benefit for overall survival. Additionally,
there was a correlation between patients with high bTMB in those
studies and longer progression-free survival (PFS) when treated
with atezolizumab. In addition, bTMB was not found to correlate
with PD-L1 expression levels as measured by tissue-based
immunohistochemistry, suggesting that bTMB, like tissue TMB,
provides independent and critical predictive information in
addition to the information furnished by PD-L1 testing.
The bTMB assay validation presentations will take place during
the following times:
Abstract #1295O -- Blood-based biomarkers for cancer
immunotherapy: Tumor mutational burden in blood (bTMB) is
associated with improved atezolizumab (atezo) efficacy in 2L+ NSCLC
(POPLAR and OAK), Sept 8, 4:00pm – 5:30pm, Madrid Auditorium (Oral
Presentation)
Abstract #102P -- Analytic validation of a next
generation sequencing assay to identify tumor mutational burden
from blood (bTMB) to support investigation of an anti-PD-L1 agent,
atezolizumab, in a first line non-small cell lung cancer trial
(BFAST), Sept 11, 1:15pm – 2:15pm, Hall 8 (Poster Presentation)
In totality, the company and its collaborators will present a
total of 19 studies at the ESMO Annual Meeting, including three
oral presentations, seven poster discussions and nine posters,
which support the integration of comprehensive genomic profiling
(CGP) and biomarkers such as tissue- and blood-based TMB to help
guide personalized cancer care. These new data include insights
into the landscape of tissue-based TMB across various types of
cancer, which may help further stratify molecular subtypes of
disease and guide more personalized treatment. Results will be
presented from a study of more than 80,000 solid tumors, a study of
more than 22,000 gastrointestinal cancers and a study of more than
2,000 melanoma cases (the largest known cohort of metastatic
melanoma cases with comprehensive genomic profiling released to
date). Together these results reveal pan-tumor and disease-specific
alterations that may inform rational selection of
immunotherapy.
Furthermore, new studies show the prevalence of TMB in subtypes
of certain cancers where immunotherapy is not often considered,
such as breast and thymic cancers. These findings may help expand
the utility of TMB into new indications.
The European Society for Medical Oncology Annual Meeting will be
held from September 8-12, 2017 in Madrid, Spain.
About Foundation Medicine
Foundation Medicine 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® and FoundationACT® 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
ability of tissue and blood based TMB to predict responses to
certain types of cancer, including NSCLC; the validation of bTMB as
a biomarker in first-line immunotherapy; the development of bTMB as
a companion diagnostic assay, the correlation of improvement in PFS
for patients with NSCLC who have high bTMB treated with
atezolizumab; the ability of CGP to improve patient outcomes; and
the continuation of the Roche/Genentech BFAST trial and the
subsequent reporting of data from the BFAST trial. 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 Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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