Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer
18 Marzo 2024 - 5:00AM
Business Wire
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a collaboration with the Fédération
Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on
the CIRCULATE-PRODIGE-70 study, a randomized, multicenter,
prospective phase III clinical trial in France investigating
molecular residual disease (MRD)-guided adjuvant treatment in stage
II colorectal cancer (CRC) patients.
The study’s main objective is to determine the benefit of
adjuvant chemotherapy (ACT) in stage II CRC patients with
detectable circulating tumor DNA (ctDNA) post-surgery. Patients who
are Signatera MRD-positive will be randomized to receive ACT
(FOLFOX 6m) or pursue observation (no chemotherapy). Patients who
are Signatera MRD-negative will be treated according to the
standard of care (observation). Approximately 1,600 patients will
be tested with Signatera, and a successful study result is expected
to pave the way for the adoption and reimbursement of Signatera in
France. The initial readout is expected in 2025.
CIRCULATE-France is complementary to the CIRCULATE-Japan and
CIRCULATE-US trials. While the Japanese and U.S. trials evaluate
the benefit of MRD-guided treatment in stage III and high-risk
stage II CRC patients, the French trial is focused on stage II
CRC.
“With more than 44,000 people in France affected by CRC, there
is a significant need for more accurate tools to identify those who
will benefit from adjuvant systemic therapy and those who can be
treated with surgery alone,” said Julien Taieb, MD, PhD, head of
the gastroenterology and gastrointestinal oncology department at
the Université Paris-Cité and principal investigator of the study.
“We believe this randomized study could establish a new standard of
MRD-guided care in stage II colorectal cancer, potentially
improving treatment decisions for thousands of patients.”
Natera has joined the study in progress. A separate
methylation-based tumor-naive ctDNA assay, developed in-house by
UMR-1138 Centre de Recherche des Cordeliers, was used to screen the
first 800 patients for eligibility. The principal investigators
elected to add Signatera, Natera’s personalized and tumor-informed
MRD test, to enhance MRD detection.
“We are pleased to have been selected to support this pivotal
trial, which underscores the value of personalized MRD testing
across various clinical settings in colorectal cancer,” said Adham
Jurdi, MD, senior medical director of oncology at Natera. “We are
encouraged by the early momentum of this study and look forward to
partnering with the Fédération Francophone de Cancérologie
Digestive to improve survival and outcomes for colorectal cancer
patients in France.”
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, ovarian cancer 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 180 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/20240318920785/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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