New Publication Demonstrates Signatera’s Ability to Risk Stratify and Detect Recurrence Early in Resected Stage I-II Lung Cancer
30 Janvier 2024 - 1:00PM
Business Wire
Clinical management was altered in 100% of
patients with a Signatera positive result
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study published in The Journal of
Thoracic and Cardiovascular Surgery demonstrating the ability of
Natera’s personalized and tumor-informed molecular residual disease
(MRD) test, Signatera, to risk stratify and detect recurrence early
in patients with resected stage I-II non-small cell lung cancer
(NSCLC). The full study can be found here.
Worldwide, lung cancer is the second most commonly diagnosed
cancer. In the U.S., NSCLC accounts for 81% of all lung cancer
diagnoses.1 About 25-30% of NSCLC patients are diagnosed with stage
I-II disease.2,3 These patients typically undergo curative-intent
complete surgical resection and may be treated with adjuvant
systemic therapy. However, 30–55% of patients develop disease
recurrence within the first five years after surgery, and five-year
overall survival ranges from 68-92% for stage I and 53-60% for
stage II NSCLC patients respectively.4,5,6
Given the significant risk of recurrence and death in NSCLC, it
is critical to accurately risk-stratify patients to identify who
may derive benefit from additional treatment after surgery. In
addition, there is a need for sensitive and specific biomarkers to
support early detection of recurrence before the onset of
disease-related symptoms at a time when therapy might provide
greater clinical benefit.
This study investigated the association of circulating tumor DNA
(ctDNA) status with recurrence-free survival (RFS), as well as
changes in clinical practice after a positive ctDNA result in
patients with resected stage I-II NSCLC. A total of 378 serial
plasma samples from 108 NSCLC patients were analyzed after surgical
resection, with a median clinical followup of 16 months.
Key findings include:
- Patients who were ctDNA-positive within 6 months post-resection
and prior to adjuvant treatment were 53-times more likely to recur
(p<0.0001) as compared to ctDNA-negative patients.
- ctDNA detection demonstrated a median lead time of 5.5 months
when compared to confirmation of recurrence by radiographic
imaging.
- Post-operative surveillance strategies were altered in 100% of
ctDNA-positive patients (earlier radiographic imaging), and
patients with PET scans positive for malignant features received
early referrals for treatment.
“This study demonstrates that serial monitoring with Signatera
can identify patients who are most likely to benefit from adjuvant
systemic therapy and/or more intensified imaging,” said Minetta
Liu, MD, chief medical officer of oncology at Natera. “With
measurable clinical impact in 100% of Signatera MRD-positive cases,
this study supports the utility of Signatera in the management of
non-metastatic, resected NSCLC.”
The study builds on previous Signatera data across early- and
late-stage NSCLC. This includes a 2023 publication in Frontiers in
Oncology, demonstrating Signatera’s ability to risk stratify and
detect progression early in unresectable NSCLC,7 as well as the
EMPower Lung-1 trial presented at the 2023 ASCO annual meeting,
which showed Signatera’s ability to monitor response to
immunotherapy and predict clinical outcomes in advanced NSCLC
patients.8 This recent work also builds upon the 2017 TRACERx
Nature publication that first reported Signatera’s ability to
detect relapse early with high sensitivity and specificity in
patients with resected NSCLC.9
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.
References
- Cancer.Net. Lung Cancer (Non-Small Cell) - Statistics.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
2023.
- Cancer of the Lung and Bronchus (Invasive). In: Howlader N,
Noone AM, Krapcho M, et al. editors. SEER Cancer Statistics Review,
1975-2014. Bethesda, MD: National Cancer Institute, 2017.
- Kocher F, Hilbe W, Seeber A, et al. Longitudinal analysis of
2293 NSCLC patients: A comprehensive study from the TYROL registry.
Lung Cancer. 2015;87(2):193-200.
doi:10.1016/j.lungcan.2014.12.006
- Uramoto H, Tanaka F. Recurrence after surgery in patients with
NSCLC. Transl Lung Cancer Res. 2014;3(4):242-249.
doi:10.3978/j.issn.2218-6751.2013.12.05
- Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in
patterns of recurrence in early-stage versus locally advanced
non-small cell lung cancer. Annals of Thoracic Surgery.
2014;98(5):1755-1761. doi:10.1016/j.athoracsur.2014.05.070
- Journal of Thoracic Oncology 2016 1139-51DOI:
(10.1016/j.jtho.2015.09.009)
- Lebow et al. ctDNA-based detection of molecular residual
disease in stage I-III non-small cell lung cancer patients treated
with definitive radiotherapy. Front. Oncol. 2023,13:1253629.
- Vokes N, Gandara D, et al. Circulating Tumor DNA (ctDNA)
Dynamics and Survival Outcomes in Patients with Advanced NSCLC and
High (>50%) PD-L1 Expression, Randomized to Cemiplimab vs
Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June
2023.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA
analysis depicts early-stage lung cancer evolution. Nature.
2017;545(7655):446-451.
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version on businesswire.com: https://www.businesswire.com/news/home/20240130015768/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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