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Foundation Medicine Publishes New Data in Nature Medicine Supporting Blood Tumor Mutational Burden (bTMB) as a Novel Predictor of Response to Cancer Immunotherapy


-- New publication details Foundation Medicine's assay's ability to
measure bTMB and to identify patients who may benefit from anti-PD-L1
therapy --

, 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."

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 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
or follow Foundation Medicine on Twitter (@FoundationATCG).

Cautionary Note Regarding Forward-Looking Statements for Foundation

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 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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