Natera Announces Completion of Enrollment to the Randomized, Phase III ALTAIR Trial of Signatera™ in Colorectal Cancer
28 Julho 2023 - 10:00AM
Business Wire
Study to evaluate clinical utility of
ctDNA-guided treatment escalation for CRC patients; results
expected to read out in mid-2024
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced the completion of enrollment to the
randomized, double-blind phase III ALTAIR clinical trial
(JapicCTI-205363/NCT04457297). ALTAIR is the circulating tumor DNA
(ctDNA)-guided treatment escalation arm of the CIRCULATE-Japan
adaptive trial platform evaluating the utility of the Signatera
molecular residual disease (MRD) test in patients with stage II-IV
resectable colorectal cancer (CRC). CIRCULATE-Japan also includes
the observational GALAXY study and the randomized phase III VEGA
trial for ctDNA-guided treatment de-escalation. The company expects
to share primary results from ALTAIR in mid-2024.
The ALTAIR investigators have met their goal to enroll >240
patients who tested ctDNA-positive at any time within 2 years after
surgery, but with no clinical or radiographic evidence of disease.
ctDNA-positive patients are randomized to placebo or TAS-102
(trifluridine/tipiracil), a therapy commonly used for patients with
metastatic CRC. The primary endpoint of the study is disease-free
survival. ctDNA clearance is a secondary endpoint.
“In this study, we aim to establish the utility of Signatera in
the adjuvant and surveillance settings by showing we can improve
outcomes for patients with detectable ctDNA before it becomes
evident on imaging,” said Dr. Takayuki Yoshino of the National
Cancer Center Hospital East, Kashiwa, Chiba, Japan and primary
investigator of the CIRCULATE-Japan trial. “Randomized studies such
as ALTAIR can help provide compelling evidence to support the use
of ctDNA testing as a tool to guide treatment decisions in
CRC.”
Completion of enrollment to ALTAIR follows the release of
multiple new datasets in 2023 highlighting the clinical utility of
Signatera in CRC. In January, the results of >1,000 patients
(>7,200 plasma time points) from GALAXY were published in Nature
Medicine, demonstrating the ability of Signatera to identify
patients with stage II-IV resectable CRC who are at an increased
risk of recurrence and to predict who is most likely to benefit
from adjuvant chemotherapy. Similar results were reported at the
American Society of Clinical Oncology (ASCO) annual meeting in June
2023 with additional data from an expanded cohort of >2,000
patients (>3,800 plasma time points) from the same study.
“The completion of enrollment to ALTAIR marks a significant
milestone that will build on recent data from the GALAXY study and
bring us one step closer to a future of ctDNA-guided cancer care,”
said Dr. Minetta Liu, chief medical officer of oncology at Natera.
“We are proud to partner with our collaborators from
CIRCULATE-Japan to accelerate precision medicine and transform care
for patients with resectable CRC.”
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. Signatera is
intended to detect and quantify cancer left in the body, at levels
down to a single tumor molecule in a tube of blood, 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 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/20230728608417/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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