First of its Kind Colorectal Cancer Data from Prospective GALAXY Study Released at ESMO; Demonstrates Signatera's Ability to Predict Overall Survival
September 14 2024 - 2:16PM
Business Wire
Shows nearly 10x advantage in overall survival
at 36 months based on ctDNA status and affirms Signatera’s ability
to predict chemotherapy benefit
Shows a 50% reduction in risk of death for
Signatera-positive patients when treated with ACT
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
and genetic testing, announced that new data from the GALAXY arm of
the ongoing CIRCULATE-Japan trial was released today at the 2024
Congress of the European Society for Medical Oncology (ESMO) in
Barcelona, Spain. GALAXY is one of the largest and most
comprehensive prospective studies of circulating tumor DNA (ctDNA)
testing in resectable colorectal cancer (CRC).
This latest analysis, which will also be published in Nature
Medicine on September 16, provides the first evidence of the
ability of Signatera-based molecular residual disease (MRD)
detection to predict overall survival (OS). The data also
demonstrates Signatera’s ability to predict adjuvant chemotherapy
(ACT) benefit in resectable CRC, with ctDNA clearance as an
indicator of a superior survival benefit compared to no
clearance.
In the study, 2,240 patients with stage II–IV CRC were monitored
using Signatera after curative-intent surgery with a median
follow-up of 23 months. Key takeaways include:
- Signatera status was predictive of overall survival.
Signatera-positivity in the post-op MRD window was found to be
significantly associated with worse OS compared to
Signatera-negative patients (HR: 9.68, p-value < 0.01) with a
36-month OS of 71.80% vs. 96.0%, respectively. This 10x advantage
in overall survival compares favorably to all known
guideline-recommended biomarkers that have HRs for overall survival
in a range of 1-4.
- Signatera status was predictive of an overall survival
benefit from adjuvant chemotherapy.
- High-risk stage II and stage III-IV patients who were
Signatera-positive after surgery and received ACT demonstrated
superior OS (adjusted HR: 0.53, p-value = 0.05), corresponding to a
50% reduction in the risk of death when treated with ACT. By
comparison, the MOSAIC trial1, which was the last practice-changing
study in adjuvant CRC, demonstrated a 16% reduction in risk of
death (HR: 0.84, p-value = 0.05).
- Signatera-negative patients did not derive an OS benefit from
ACT (adjusted HR: 0.53, p-value = 0.13).
- Signatera status remained the most significant predictor of
recurrence. Signatera-positivity after surgery was the single
most significant prognostic factor associated with inferior DFS (HR
12.08, p-value <0.01) and OS (HR 9.87, p-value <0.01) in a
multivariate analysis that included all clinicopathologic risk
factors currently in use. This is also reflected by the 36-month
DFS difference between Signatera-positive and Signatera-negative
patients at 16.7% (95% CI: 12.1–21.9%) versus 83.5% (95% CI:
81.2%–85.6%), respectively. The association of Signatera-positivity
with a significantly increased risk for recurrence was observed
across all pathologic stages.
- Sustained Signatera clearance after ACT was associated with
improved survival. Patients who clear ctDNA and remained
Signatera-negative (referred to as “sustained clearance”) had
superior survival benefit with 24-month OS of 100%. This compares
to patients who cleared ctDNA for a period of time but later become
Signatera-positive (referred to as “transient clearance”), with
24-month OS of 82%, and patients who did not achieve ctDNA
clearance, with 24-month OS of 61%. This finding further supports
the utility of sustained ctDNA clearance as a surrogate endpoint
for long-term outcomes.
“We now have compelling prospective evidence from a large trial
of more than 2,200 patients that clearly reinforces the link
between MRD status and overall survival,” said Yoshiaki Nakamura,
MD, PhD, co-author of the paper and principal investigator of the
study from the National Cancer Center Hospital East in Kashiwa,
Chiba, Japan. “These findings suggest that Signatera can predict
post-surgical outcomes for colorectal cancer patients with great
precision, redefining the future of personalized medicine and
providing the potential to significantly improve outcomes for a
greater number of patients.”
“The GALAXY data released today builds on an earlier analysis
from the same study that was published in Nature Medicine in 2023,”
said Minetta Liu, MD, chief medical officer of oncology at Natera.
“Introducing 36-month, first-of-its-kind data on overall survival
is an important milestone that reinforces the potential to improve
outcomes for patients diagnosed with colorectal cancer. The updated
data affirms ctDNA status as a critical measure both for prognosis
and for predicting which patients may truly benefit from adjuvant
chemotherapy.”
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 70 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 200 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.
References
- Thierry André et al., Improved Overall Survival With
Oxaliplatin, Fluorouracil, and Leucovorin As Adjuvant Treatment in
Stage II or III Colon Cancer in the MOSAIC Trial. JCO 27,
3109-3116(2009). DOI:10.1200/JCO.2008.20.6771
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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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