Foundation Medicine Publishes New Data in Nature Medicine Supporting Blood Tumor Mutational Burden (bTMB) as a Novel Predicto...
06 Agosto 2018 - 1:00PM
Business Wire
-- New publication details Foundation
Medicine’s assay’s ability to measure bTMB and to identify patients
who may benefit from anti-PD-L1 therapy --
Foundation Medicine, today announced the publication of the
results of a large study demonstrating that its novel,
investigational assay to measure blood tumor mutational burden
(bTMB) can help predict response to the anti-PD-L1 immunotherapy,
atezolizumab, (TECENTRIQ®) in patients with previously treated
non-small cell lung cancer (NSCLC). The study, published in the
journal Nature Medicine, was the result of a collaboration between
Foundation Medicine and Genentech, a member of the Roche Group, and
demonstrates the potential of bTMB to expand precision oncology
approaches for patients with advanced cancers, including metastatic
lung cancer. In addition, these results show that bTMB may be an
independent predictor of clinical benefit, regardless of PD-L1
expression as assessed by immunohistochemistry.
“A significant proportion of patients with advanced lung cancer
do not have adequate tissue for traditional biomarker testing.
These study results represent an important advance for the liquid
biopsy field and suggest that measuring TMB in the blood with our
novel assay can help identify patients more likely to benefit from
anti-PD-L1 immunotherapy,” said Vincent Miller, M.D., chief medical
officer at Foundation Medicine. “We look forward to further
developing this assay through ongoing clinical trials and
ultimately as a companion diagnostic to help oncologists make the
most informed decisions possible, even when a tissue sample is not
feasible.”
In the study, clinical data for the novel bTMB assay was
reported from a retrospective analysis of more than 1,000 samples
from patients with previously treated, advanced NSCLC who
participated in Genentech’s Phase II POPLAR and Phase III OAK
clinical trials. The study used samples from the POPLAR trial to
identify a range of bTMB thresholds that correlated with clinically
meaningful outcomes, which were then confirmed using samples from
the OAK study. Within the OAK study, patients with bTMB ≥ 16 total
mutations (14 mut/Mb) showed significantly improved
progression-free survival when treated with atezolizumab as
compared to those patients with bTMB ≥ 16 total mutations (14
mut/Mb) treated with docetaxel chemotherapy (Hazard Ratio=0.65 [95%
CI: 0.47, 0.92]; p=0.013). According to the study’s first author,
David Gandara, M.D. of the UC Davis Comprehensive Cancer Center,
“These are exciting times in lung cancer immunotherapy. Having a
blood test that can identify those patients most likely to benefit
would be a huge advantage for both physicians and patients. This
publication is the first step toward what I anticipate will be full
clinical application of this assay.”
This bTMB assay is being prospectively evaluated in two
Genentech studies: in the Phase III Blood First Assay Screening
Trial (BFAST) as a companion diagnostic assay to validate bTMB as a
non-invasive biomarker of response to first-line atezolizumab in
advanced NSCLC patients, and in the single arm Phase II Blood
First-Line Ready Screening Trial (B-F1RST) evaluating atezolizumab
monotherapy in first-line NSCLC.
In April 2018, the U.S. Food and Drug Administration (FDA)
granted a Breakthrough Device designation for Foundation Medicine’s
new liquid biopsy assay, which will expand upon its current liquid
biopsy assay to include genomic biomarkers for microsatellite
instability (MSI) and bTMB. If approved, this test could be the
first FDA-approved liquid biopsy assay to incorporate multiple
companion diagnostics (CDx) and multiple biomarkers to inform the
use of targeted oncology therapies, including immunotherapies.
About Foundation MedicineFoundation 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).
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 ability of tissue and blood based TMB to predict
response to immunotherapy, including the anti-PD-L1 immunotherapy,
atezolizumab; the validation of bTMB as a biomarker in first-line
immunotherapy; the benefits of Foundation Medicine’s bTMB assay in
the treatment of patients with advanced NSCLC; the development of a
bTMB assay as a companion diagnostic assay; the continuation of the
Roche/Genentech BFAST and B-FIRST trials and the subsequent
reporting of data from these trials; the technical specifications
of Foundation Medicine’s new assay; the scope and timing of any
approval of the liquid biopsy assay as a medical device by the FDA,
including its potential approval and use as a companion diagnostic;
and the liquid biopsy assay’s ability to inform the use of targeted
oncology therapies, including immunotherapies, or enhance patient
access to targeted therapies and 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 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 or biomarkers in the same manner as prior clinical
data; the FDA does not approve Foundation Medicine’s assay as a
medical device; the FDA is delayed in the completion of its review
process; 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.
Foundation Medicine® is a registered trademark of Foundation
Medicine, Inc.
TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
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version on businesswire.com: https://www.businesswire.com/news/home/20180806005446/en/
Foundation MedicineLee-Ann Murphy,
617-245-3077pr@foundationmedicine.com
Foundation Medicine, Inc. (NASDAQ:FMI)
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