Natera Announces Randomized, Phase III TREAT ctDNA Trial in Early-Stage Breast Cancer
08 Novembro 2023 - 11:10AM
Business Wire
Study to evaluate effectiveness of switching
treatment to elacestrant in early breast cancer based on the
detection of molecular relapse with Signatera™
Approximately 1,900 early-stage breast cancer
patients to be screened at 120+ sites in Europe
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced its personalized and tumor-informed
molecular residual disease (MRD) test, Signatera, will be used in a
new breast cancer study called TREAT ctDNA (EORTC 2129-BCG). This
international, multi-center, randomized, phase III clinical trial
is being conducted by the European Organisation for Research and
Treatment of Cancer (EORTC) Breast Cancer Group in collaboration
with Natera and Menarini Group (Menarini), a leading international
pharmaceutical and diagnostics company.
The primary objective of the study is to evaluate whether
elacestrant (ORSERDU®), a new oral endocrine monotherapy, can delay
and/or prevent occurrence of distant metastasis or death compared
to standard endocrine therapy in ER+/HER2- early-stage breast
cancer patients with molecular relapse, which is defined as the
presence of circulating tumor DNA (ctDNA) without clinical or
radiographic evidence of recurrence. Over 200 patients who are
ctDNA-positive by Signatera will be randomized to continue standard
endocrine treatment or switch to elacestrant. Patients in both the
control and experimental arms are expected to potentially benefit
from timely detection of recurrence.
“We are excited to offer to our high-risk, ctDNA positive,
ER+/HER2- early-stage breast cancer patients the possibility to
participate in the TREAT ctDNA trial. We aim to study the value of
the new selective estrogen receptor degrader (SERD), elacestrant,
in reducing the rate of late distant relapses for these patients,”
said Prof. Michail Ignatiadis, chair of the EORTC Breast Cancer
Group and director of the Breast Medical Oncology Clinic and
Program at the Jules Bordet Institut.
“We are grateful to partner with EORTC in our efforts to
establish the utility of treatment on molecular recurrence,
prompted by using Signatera to identify MRD-positive patients
before clinically apparent relapse,” said Minetta Liu, M.D., chief
medical officer of oncology at Natera. “Collaborations with leading
clinical trial organizations like EORTC are needed as we seek to
demonstrate the power of treatment on molecular recurrence across
cancer indications. We believe this represents a paradigm shift in
a patient’s cancer journey, wherein ctDNA testing may serve as a
critical tool to catch relapse earlier, enable treatment while
disease burden is still low, and ultimately improve patient
outcomes.”
The study will screen approximately 1,900 patients across more
than 120 sites in 12 countries throughout Europe and is expected to
launch before the end of the year.
About Elacestrant (ORSERDU®)
European Union Indication: ORSERDU (elacestrant) was approved by
the European Commission in September 2023 as a monotherapy for the
treatment of postmenopausal women, and men, with estrogen receptor
(ER)-positive, HER2-negative, locally advanced or metastatic breast
cancer (mBC) with an activating ESR1 mutation who have disease
progression following at least one line of endocrine therapy
including a CDK4/6 inhibitor. More information, including
prescribing information and important safety information, is
available 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/20231107253448/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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