Natera Presents New Signatera™ MRD Data Across Breast Cancer Treatment Settings at SABCS 2023
06 Dezembro 2023 - 10:30AM
Business Wire
Includes new data from prospective clinical
trials in HR+/HER2- breast cancer evaluating treatment on molecular
recurrence (TOMR) and additional real-world data across all breast
cancer subtypes
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced new data being presented on its
personalized and tumor-informed molecular residual disease (MRD)
test, Signatera, at the 2023 San Antonio Breast Cancer Symposium
(SABCS) in San Antonio, Texas.
Natera and its collaborators are presenting two poster spotlight
discussions and three posters. The presentations feature
tumor-informed MRD data spanning the neoadjuvant, adjuvant,
surveillance, and metastatic treatment settings, including analyses
from the DARE, monarchE, and LEADER trials in HR+/HER2- breast
cancer.
“We are excited to showcase our leadership at SABCS with
thought-provoking new data that demonstrate our commitment to
personalizing patient care across the breast cancer continuum,”
said Minetta Liu, MD, chief medical officer of oncology, at Natera.
“We are highly encouraged by the excellent preliminary findings
from prospective, interventional clinical trials such as DARE and
LEADER, which we believe will further demonstrate the utility of
treatment on molecular recurrence with Signatera.”
Highlights from selected abstracts
include:
PS06-02 | Poster Spotlight Discussion | DARE Study |
HR+/HER2- Surveillance (TOMR) | Presenter: Lajos Pusztai, MD
Circulating tumor DNA (ctDNA) monitoring of estrogen
receptor-positive, human epidermal growth factor receptor
2-negative (ER+/HER2-) high risk breast cancer during adjuvant
endocrine therapy
DARE is a first-of-its-kind, multi-center, prospective,
randomized clinical trial, which was first announced in October
2020. An interim readout of over 400 patients prescreened for ctDNA
detection and enrollment in the interventional trial demonstrates
that ~9% of patients tested ctDNA-positive with a median screening
time of 13.4 months per patient. Over 70% of patients experienced
molecular-only relapse (i.e. ctDNA positivity with no evidence of
metastatic disease on imaging), which is the highest rate seen in a
prospective study to date and demonstrates the feasibility of TOMR
study designs in breast cancer. These patients were successfully
randomized to receive endocrine therapy in combination with
palbociclib vs. continuing standard of care. Initial ctDNA dynamics
were presented, including clearance events. The association of this
data with treatment benefit will be presented at future
meetings.
PS06-01 | Poster Spotlight Discussion | monarchE Study |
HR+/HER2- Surveillance (adjuvant CDK4/6i) | Presenter: Stephanie
Graff, MD, FACP Results from a study exploring ctDNA detection
in the monarchE trial of adjuvant abemaciclib with endocrine
therapy in HR+, HER2-, node-positive, high-risk early breast
cancer
This study investigated the technical feasibility of ctDNA
testing beginning prior to adjuvant CDK4/6i therapy and examined
rates of ctDNA persistence and clearance in a highly selected
cohort of 178 patients from the phase 3 monarchE trial, which
excluded any recurrences in the first 24 months after surgery.
Persistent ctDNA positivity during two years of treatment was found
to be associated with a 100% risk of relapse. Additionally, none of
the patients developed recurrence if they were initially
ctDNA-positive and later became ctDNA-negative during treatment
(ctDNA clearance). An analysis of an expanded cohort is ongoing,
which will be more reflective of the intent-to-treat population and
will include additional time points and recurrent cases within the
2-year treatment period.
Below are additional Natera abstracts
being presented at SABCS:
- PO3-13-09 | Poster Session 3 | LEADER Study | HR+/HER2-
Surveillance (TOMR) | Presenter: Arielle Medford, MD
Personalized ctDNA testing for detection of MRD in patients with
localized HR+ breast cancer: temporal dynamics and impact on
clinical outcomes.
- PO4-15-12 | Poster Session 4 | Neoadjuvant Treatment
Monitoring (all subtypes) | Presenter: Mridula George, MD
Personalized ctDNA monitoring to predict response to neoadjuvant
therapy in patients with early-stage breast cancer
- PO5-13-12 | Poster Session 5 | Metastatic Invasive Lobular
Carcinoma (mILC) Treatment Monitoring (all subtypes) | Presenter:
Steffi Oesterreich, PhD Personalized ctDNA testing for
recurrence detection and treatment response monitoring in patients
with mILC
All abstracts can be found on the SABCS website here.
About Signatera
Signatera is a personalized, tumor-informed, molecular residual
disease test for patients previously diagnosed with cancer.
Custom-built for each individual, Signatera uses circulating tumor
DNA to detect and quantify cancer left in the body, identify
recurrence earlier than standard of care tools, and help optimize
treatment decisions. The test is available for clinical and
research use and is covered by Medicare for patients with
colorectal cancer, breast cancer (stage IIb and higher) and muscle
invasive bladder cancer, as well as for immunotherapy monitoring of
any solid tumor. Signatera has been clinically validated across
multiple cancer types and indications, with published evidence in
more than 50 peer-reviewed papers.
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 150 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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231206078253/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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