SAGITTARIUS is Natera's first interventional
trial using SignateraTM to select patients for targeted therapy in
early-stage colon cancer
Approximately 700-900 patients expected to be
enrolled across more than 20 sites
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
and genetic testing, today announced the enrollment of the first
patients in the SAGITTARIUS clinical trial. Sponsored by The AIRC
Institute of Molecular Oncology (IFOM-ETS) and funded by the
European Union Horizon Europe Programme, SAGITTARIUS is a global,
randomized, phase III clinical trial designed to evaluate the use
of Signatera to guide personalized adjuvant treatment strategies
for patients with colon cancer.
The study aims to enroll approximately 700-900 stage III and
high-risk stage II colon cancer patients following surgical
resection.
- Signatera-positive patients will be randomized to receive
either genotype-guided therapy tailored to their individual tumor
mutational profile or six months of standard chemotherapy. The
trial’s investigational arm will explore the potential of
administering immunotherapy or targeted agents approved for
metastatic colon cancer earlier in the disease course to increase
the proportion of patients cured with adjuvant therapy. This
genomically-driven approach will focus on mismatch repair status,
POLE, RAS/RAF mutation status, and HER2 amplification status.
- For Signatera-negative patients, the trial will compare
physician choice treatments with options for de-escalation to
observation or single-agent capecitabine for six months.
SAGITTARIUS includes collaborations with 9 partners in 5
countries in Europe, and a network of 26 clinical centers in Italy,
Spain, and Germany.
“The enrollment of the first patients in SAGITTARIUS represents
a significant milestone in a trial that has the potential to
transform treatment approaches for colorectal cancer,” said Silvia
Marsoni, MD, PhD, head of the precision oncology unit at IFOM ETS
and scientific coordinator of the SAGITTARIUS Project.
“The trial aims to move beyond the traditional
one-size-fits-all, post-surgical standard of care with chemotherapy
by introducing a truly personalized treatment approach tailored to
each patient,” said Adham Jurdi, MD, senior medical director of
oncology at Natera. “Signatera-positive patients will receive
adjuvant therapies matched to their specific mutational profiles.
Additionally, we are optimistic that the study will generate
evidence to support the de-escalation of chemotherapy for
Signatera-negative patients.”
Clara Montagut, MD, PhD, head of the gastrointestinal cancer
unit at Hospital del Mar in Barcelona, Spain, and principal
investigator of the SAGITTARIUS clinical trial, further emphasized
the study’s innovative goals, noting, “We aim to anticipate the use
of therapies tailored to the molecular landscape of the patient’s
tumor, including immunotherapy and targeted therapies with proven
efficacy in the metastatic setting within the adjuvant treatment
context. To our knowledge, SAGITTARIUS is currently the only trial
pursuing this approach in the field of liquid biopsy research.”
About the SAGITTARIUS Horizon Europe project
The SAGITTARIUS clinical trial is part of a wider effort, the
SAGITTARIUS project, funded by the European Union Horizon Europe
Programme. The SAGITTARIUS project, which also includes health cost
and quality of life research to comprehensively assess the full
cost-effectiveness of interventional liquid biopsy, aims to pave
the way for more effective, tailored treatments that enhance both
outcomes and quality of life for colon cancer patients, while
potentially lowering the cost impact on private and public health
systems and reducing treatment disparities. The SAGITTARIUS project
is a collaboration of 9 partners in Italy, Spain, Germany, Belgium
and Estonia. For more information, visit
www.sagittarius-horizon.eu.
About IFOM ETS
IFOM ETS - the AIRC Institute of Molecular Oncology is a leading
cancer research institute based in Milan, Italy, with international
outreach in Japan. The institute, supported by the AIRC Foundation
for Cancer Research, is focused on the study of cancer formation
and development at molecular level, with a strong emphasis on
rapidly translating research findings into clinical benefit for
cancer patients. With the expertise in trial design and management
of its Precision Oncology Unit, IFOM is the sponsor of the
SAGITTARIUS clinical trial and the coordinator of the homonymous
Horizon Europe project. For more information, visit
www.ifom.eu/en/.
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 over 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic 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 250 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/20241212128799/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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