New Study Validates Signatera™ in Endometrial Cancer
05 Februar 2024 - 2:00PM
Business Wire
Study shows ctDNA positivity is the most prognostic factor,
demonstrating the potential for Signatera to redefine adjuvant
treatment pathways in endometrial cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study published in Gynecologic
Oncology validating its personalized and tumor-informed molecular
residual disease (MRD) test, Signatera, in endometrial cancer. The
full study can be found here.
Endometrial cancer (EC) is the most common gynecologic
malignancy in the United States. Disease incidence has been rising,
but mortality has been rising even faster, potentially due to a
higher frequency of aggressive high-risk subtypes of the
disease.1-4 More accurate risk stratification is needed to identify
those patients who will benefit from therapeutic interventions with
curative intent. Current guidelines rely on clinicopathological
risk factors to define risk groups and aid in adjuvant treatment
decision-making.5,6 However, the decision to administer adjuvant
therapy for patients with high-risk and high-intermediate-risk EC
remains unclear, creating the need for better diagnostic tools to
help determine who is most likely to benefit from
treatment.7-10
This real-world study analyzed 267 plasma samples drawn after
surgery from 101 patients with EC. The patient cohort was composed
of multiple histological subtypes, with patients stratified based
on clinicopathological risk factors into high-risk (52%),
high-intermediate (22%), low-risk (15%), and other (12%). Key
findings include:
- Patients who tested Signatera MRD-positive at either a single
time point or longitudinally experienced significantly higher rates
of recurrence than those who remained Signatera-negative (58% and
52%, vs. 6% and 0%, respectively), regardless of mismatch repair
(MMR) or p53 status.
- Signatera MRD status was the only significant risk factor for
recurrence when adjusted for clinicopathological risk groups and
molecular subgroups such as MMR and p53 status (HR=18.9,
p=.001).
“This study provides clinical validation of Signatera as a
powerful post-surgical biomarker of recurrence risk for patients
with endometrial cancer,” said Minetta Liu, MD, chief medical
officer of oncology at Natera. “Use of Signatera in clinical
workflows may help physicians and patients tailor their adjuvant
treatment decisions based on direct evidence of molecular residual
disease.”
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 60 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.
References
- Temkin SM, Kohn EC, Penberthy L, Cronin KA, Rubinsak L, Dickie
LA, et al. Hysterectomy-corrected rates of endometrial cancer among
women younger than age 50 in the United States. Cancer Causes
Control. 2018;29:427–33.
- Siegel RL, Miller KD, Fuchs HE, and Jemal A. "Cancer
statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33.
- National Cancer Institute. Surveillance, Epidemiology, and End
Results Program. Cancer stat facts: uterine cancer. Accessed
February 2, 2024.
https://seer.cancer.gov/statfacts/html/corp.html.
- Siegenthaler F, Lindemann K, Epstein E, et al. Time to first
recurrence, pattern of recurrence, and survival after recurrence in
endometrial cancer according to the molecular classification.
Gynecol Oncol. 2022;165(2):230-238.
- Concin N, Matias-Guiu X, Vergote I, et al. ESGO/ESTRO/ESP
guidelines for the management of patients with endometrial
carcinoma. Int J Gynecol Cancer. 2021;31(1):12-39.
- Abu-Rustum N, Yashar C, Arend R, et al. Uterine Neoplasms,
Version 1.2023, NCCN Clinical Practice Guidelines in Oncology. J
Natl Compr Canc Netw. 2023;21(2):181-209.
- Keys HM, Roberts JA, Brunetto VL, et al. A phase III trial of
surgery with or without adjunctive external pelvic radiation
therapy in intermediate risk endometrial adenocarcinoma: a
Gynecologic Oncology Group study. Gynecol Oncol.
2004;92(3):744-51.
- Nout RA, Smit VT, Putter H et al. Vaginal brachytherapy versus
pelvic external beam radiotherapy for patients with endometrial
cancer of high-intermediate risk (PORTEC-2): an open-label,
non-inferiority, randomised trial. Lancet.
2010;375(9717):816-23.
- Group AS, Kitchener H, Swart AM, Qian Q, Amos C, and Parmar MK.
Efficacy of systematic pelvic lymphadenectomy in endometrial cancer
(MRC ASTEC trial): a randomised study. Lancet.
2009;373(9658):125-36.
- de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant
chemoradiotherapy versus radiotherapy alone for women with
high-risk endometrial cancer (PORTEC-3): final results of an
international, open-label, multicentre, randomised, phase 3 trial.
Lancet Oncol. 2018;19(3):295-309.
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version on businesswire.com: https://www.businesswire.com/news/home/20240205986663/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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