Updated Data from CIRCULATE-Japan Presented at ESMO 2023 Reinforces Signatera’s Prognostic and Predictive Value in Analysis of 2,500+ Colorectal Cancer Patients
22 Outubro 2023 - 2:00PM
Business Wire
Builds on published evidence with twice as many
patients and disease-free survival data extended to 24 months
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced updated data from the GALAXY arm of the
CIRCULATE-Japan trial further showcasing the ability of the
Signatera™ molecular residual disease (MRD) test to help identify
patients with resectable colorectal cancer (CRC) who are at an
increased risk of recurrence and predict who are most likely to
benefit from adjuvant chemotherapy.
In a presentation today at the 2023 European Society for Medical
Oncology (ESMO) Congress in Madrid, Natera and its collaborators
shared an expanded GALAXY analysis that builds on results published
in January 2023 in Nature Medicine. With 2,625 CRC patients and
disease free survival (DFS) assessment at 24 months, this analysis
includes more than twice the number of patients and significantly
longer follow-up than the previously published 18-month
findings.
Key highlights include:
- Circulating tumor DNA (ctDNA) negative patients continued to
show exceptional DFS regardless of adjuvant chemotherapy (ACT)
treatment.
- No significant difference in DFS at 24 months was observed for
ctDNA negative patients receiving ACT compared to those with no ACT
(88.3% DFS v. 89.9%, p-value 0.156).
- Lack of absolute risk reduction between the two groups further
improves on the previously published analysis.
- The presence of post-surgical ctDNA was the most significant
prognostic factor for disease recurrence and was predictive of
chemotherapy benefit.
- ctDNA positive patients receiving ACT had significantly higher
DFS at 24 months compared to those with no ACT (38.6% DFS v. 16.1%,
p-value <0.01).
- Patients with ctDNA positive results had significantly lower
DFS at 24 months than ctDNA negative patients (31% v. 89%, p-value
<0.01).
- In a multivariate analysis, ctDNA status continued to be the
most prognostic factor for cancer recurrence (HR 10.44).
- Early ctDNA dynamics were predictive of recurrence.
- Changes in ctDNA status at 3 months post-surgery were
significantly associated with DFS at 24 months.
“The latest data from one of the largest prospective studies of
MRD testing in colorectal cancer provides further evidence that
Signatera can help clinicians determine which patients are most
likely to benefit from adjuvant chemotherapy, while also showing
that postoperative ctDNA status is a highly prognostic factor for
cancer recurrence,” said the study’s principal investigator,
Takayuki Yoshino, M.D., of the National Cancer Center Hospital
East, Kashiwa, Chiba, Japan. “With a larger cohort of patients and
longer-term follow up, this updated analysis builds upon previously
published findings and shows how ctDNA can play a critical role in
monitoring disease progression and guiding adjuvant treatment.”
Additional randomized, phase III studies designed to evaluate
Signatera MRD-guided adjuvant strategies in CRC are also underway
as part of the CIRCULATE-Japan platform. These include the
randomized ALTAIR trial, which aims to establish the utility of ACT
escalation as well as treatment on molecular recurrence in the
MRD-positive population; and the VEGA trial, which is analyzing
de-escalation of ACT in the MRD-negative population.
“With these updated findings from GALAXY, the upcoming analyses
from the VEGA and ALTAIR trials, and other anticipated read-outs
from key studies in our pipeline, Natera continues to demonstrate
leadership in data generation from a broad clinical roadmap in
colorectal cancer,” said Minetta Liu, M.D., chief medical officer
of oncology at Natera. “We are extremely pleased to continue the
collaboration with our international partners, including NCC East
in Japan, in building clinical evidence to transform disease
management for patients with cancer.”
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/20231022276686/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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