AMPLIFY-201, a phase I trial evaluating
treatment response to the ELI-002 vaccine, is the first study to
read out using ctDNA to enroll and monitor patients with solid
tumors
PANDA study shows ctDNA status in patients with
gastric and gastroesophageal cancers is strongly associated with
recurrence risk and pathologic response
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced the publication of two new studies in
Nature Medicine evaluating Natera’s personalized and tumor-informed
molecular residual disease (MRD) test, Signatera.™
The first study shows results from the single-arm, phase I
AMPLIFY-201 trial evaluating the ELI-002 cancer vaccine. The study
enrolled a total of 25 patients (20 pancreatic, 5 colorectal), 21
of whom were Signatera-positive after locoregional treatment.
Signatera dynamics were also used as a secondary endpoint to assess
tumor biomarker response, together with serum tumor antigens. This
study is the first of its kind to have utilized circulating tumor
DNA (ctDNA)-positivity in conjunction with other tumor biomarkers
for enrollment, highlighting the use of Signatera for detecting
early evidence of anti-tumor activity of a drug candidate to help
assess for a dose response.
The study reported that tumor biomarker responses were observed
in 21/25 patients (84%), and ctDNA clearance was observed in 6/25
patients (24%). In contrast, serum tumor antigens declined but did
not clear, highlighting the potential utility of ctDNA to be used
as a reliable surrogate biomarker for treatment efficacy.
“We are excited about our partnership with Natera, which has
resulted in a successful prospective, phase I clinical trial
focused on trial enrichment by enrolling Signatera-positive
patients and monitoring therapy response in patients receiving a
cancer vaccine,” said Christopher Haqq, MD, PhD, Elicio
Therapeutic, Inc’s executive vice president, head of research and
development, and chief medical officer. “We are optimistic about
the potential for this study to improve outcomes for patients with
pancreatic and colorectal cancer, who face clinical challenges and
are often incurable when ctDNA is detected after treatment.”
A second study published in Nature Medicine, called PANDA, is a
single-arm, open-label, phase II study that investigated
preoperative atezolizumab plus chemotherapy in patients with
resectable, non-metastatic gastric and gastroesophageal junction
adenocarcinoma. The study included 20 patients who underwent
surgery and were evaluated for safety, pathologic response, and
survival endpoints, and Signatera was used to detect and monitor
ctDNA dynamics in all 20 patients.
The PANDA study found that ctDNA clearance after neoadjuvant
therapy correlated with pathologic response in 11/11 patients,
while 3/6 patients with poor pathologic response remained
ctDNA-positive (P=0.029). None of the patients with complete
pathologic response (pCR) were ctDNA-positive, and among the
nonresponders who were ctDNA negative (n=3), the study reported
superior long-term outcomes. Additionally, ctDNA-positivity at the
MRD and follow-up time points was associated with a recurrence rate
of 100%.
“We’re pleased to see these excellent results from the PANDA
study which demonstrate the strong correlation between ctDNA and
pathologic response pre-surgery and the therewith associated
recurrence risk, highlighting the potential utility of Signatera in
gastric and gastroesophageal cancers,” said Myriam Chalabi MD, PhD,
medical oncologist, Netherlands Cancer Institute, and principal
investigator of the PANDA study.
“PANDA and AMPLIFY-201 add to the growing number of studies
supporting the use of Signatera across various GI indications,
showing the promise of tumor-informed ctDNA testing to help
personalize treatment strategies,” said Alexey Aleshin, general
manager of oncology and early cancer detection at Natera. “These
studies also point to the valuable insights longitudinal ctDNA
monitoring can provide in the evaluation of novel therapies.”
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 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/20240125943032/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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