Signatera ctDNA dynamics are both predictive
and prognostic in neoadjuvant TNBC.
Lead time up to 30
months between Signatera positivity and radiographic
recurrence.
AUSTIN,
Texas, April 11, 2022 /PRNewswire/ -- Natera,
Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing,
today announced that it will present new data relating to its
personalized and tumor-informed molecular residual disease (MRD)
test, Signatera™, at the annual meeting of the American Association
for Cancer Research taking place April
8 – 13, 2022.
Natera will have two data presentations in early-stage
breast cancer, focused on patients that are high-risk hormone
receptor-positive/HER2-negative (HR+/HER2-) and/or with triple
negative breast cancer (TNBC). These data are the latest in a
fast-growing body of evidence supporting the clinical use of
Signatera MRD in breast cancer across all major subtypes.
Details about the presentations are as follows:
Abstract # 2796 | Poster Presentation | Date/time:
Tuesday April 12, 9am-12:30pm
Circulating Tumor DNA Prognosis in Adjuvant Triple
Negative Breast Cancer
Tumor tissue and longitudinal plasma samples were collected
post-surgery from 186 TNBC patients enrolled in the phase 3
BEATRICE clinical trial (NCT00528567) and analyzed using a
research-use-only version of Natera's personalized ctDNA
technology. The results demonstrate that ctDNA status in samples
collected post-surgery provided independent prognostic value beyond
the known risk factors of lymph node involvement, tumor size and
presence of tumor infiltrating lymphocytes.
- 19.9% of patients with early-stage TNBC were found to have
detectable ctDNA after surgery, which was strongly associated with
inferior outcomes (IDFS and OS)
- Lead time between first ctDNA positivity and radiographic
recurrence was 6.1 months at the median, ranging up to 30.5
months
"TNBC is the most aggressive type of breast cancer, with a major
unmet need for better diagnostic tools to identify high risk
patients and inform cancer management," said Angel Rodriguez, M.D., medical director of
oncology at Natera. "This study builds upon the prior scientific
literature, further validating Signatera as a strong prognostic
factor in TNBC, with significant potential to improve patient
care."
Abstract # 7878 | Poster Presentation | Date/time:
Tuesday April 12, 9am-12:30pm
Comparison of the Predictive and Prognostic Significance of
Circulating Tumor DNA in Patients with High-Risk HER2-Negative
Breast Cancer Receiving Neoadjuvant Chemotherapy
This study analyzed 734 blood samples collected serially during
neoadjuvant chemotherapy (NAC) from 106 HR+/HER2- and 97 TNBC
patients enrolled in the I-SPY2 trial, one of the largest trials in
the neoadjuvant setting.
- In TNBC, early clearance of ctDNA after just three weeks of
treatment was a significant predictor of pathologic complete
response
- Patients who were ctDNA-negative after NAC, in both subtypes,
showed significantly improved distant recurrence-free survival,
even among those patients who did not achieve pathologic complete
response
"This data shows the potential utility of personalized ctDNA
monitoring with Signatera during neoadjuvant treatment, giving us
the ability to, in conjunction with MR imaging, improve the
prediction of response early in the course of treatment," said
Laura Esserman, M.D., M.B.A., and
Laura van 't Veer, Ph.D., breast
cancer specialists on the I-SPY2 Trial. "We are integrating this
technology into the I-SPY Trial and prospectively testing it to
help improve patient care in breast cancer."
More information on Signatera in breast cancer is available
here.
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA)
test for treatment monitoring and molecular residual disease (MRD)
assessment in patients previously diagnosed with cancer. The test
is available for both clinical and research use, and has been
granted three Breakthrough Device Designations by the FDA for
multiple cancer types and indications. The Signatera test is
personalized and tumor-informed, providing each individual with a
customized blood test tailored to fit the unique signature of
clonal mutations found in that individual's tumor. This maximizes
Signatera's accuracy for detecting the presence or absence of
residual disease in a blood sample, even at levels down to a single
tumor molecule in a tube of blood. Signatera is intended to detect
and assess how much cancer is left in the body, to identify
recurrence earlier and to help optimize treatment decisions.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated
to oncology, women's health, and organ health. We aim to make
personalized genetic testing and diagnostics part of the standard
of care to protect health, and inform earlier, more targeted
interventions that help lead to longer, healthier lives. Natera's
tests are validated by more than 100 peer-reviewed publications
that demonstrate high accuracy. Natera operates ISO 13485-certified
and CAP-accredited laboratories certified under the Clinical
Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information,
visit www.natera.com.
Forward-Looking
Statements
All statements other than statements of historical facts
contained in this press release are forward-looking statements and
are not a representation that Natera's plans, estimates, or
expectations will be achieved. These forward-looking statements
represent Natera's expectations as of the date of this press
release, and Natera disclaims any obligation to update the
forward-looking statements. These forward-looking statements are
subject to known and unknown risks and uncertainties that may cause
actual results to differ materially, including with respect to our
efforts to develop and commercialize new product offerings, whether
the results of clinical or other studies will support the use of
our product offerings, the impact of results of such studies, our
expectations of the reliability, accuracy and performance of our
tests, or of the benefits of our tests and product offerings to
patients, providers and payers Additional risks and uncertainties
are discussed in greater detail in "Risk Factors" in Natera's
recent filings on Forms 10-K and 10-Q and in other filings Natera
makes with the SEC from time to time. These documents are available
at www.natera.com/investors and www.sec.gov.
Contacts
Investor Relations: Mike Brophy,
CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa,
Communications, Natera, Inc., pr@natera.com
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SOURCE Natera, Inc.