New MRD Publication in Unresectable Stage I-III Lung Cancer Demonstrates Signatera’s Ability to Risk Stratify and Detect Progression Early
04 Outubro 2023 - 10:00AM
Business Wire
Test performance showed 82% pre-treatment
detection, with 100% longitudinal sensitivity and 100% longitudinal
specificity to disease progression
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study published in Frontiers in
Oncology demonstrating the ability of Natera’s personalized and
tumor-informed molecular residual disease (MRD) test, Signatera™,
to detect progression early, with high sensitivity and specificity,
and risk stratify patients with unresectable stage I-III non-small
cell lung cancer (NSCLC) treated with definitive radiotherapy. The
full study can be found here.
Worldwide, lung cancer is the second most commonly diagnosed
cancer. NSCLC is the most common type of lung cancer in the U.S.,
accounting for 81% of all lung cancer diagnoses.1 For early-stage
NSCLC patients, 36% are inoperable and primarily managed with
curative-intent radiotherapy, with or without chemotherapy;2
however, despite the treatment, 46% of patients still experience
disease progression.3,4 Accurate risk assessment can identify
patients who might derive benefit from additional treatment after
radiotherapy, versus patients with more favorable outcomes who
could be spared the unnecessary treatment toxicity. In addition,
there is a need for sensitive and specific biomarkers to support
early detection of progression before the onset of disease-related
symptoms, at a time when therapy might provide greater clinical
benefit.
This prospective study investigated the association of
circulating tumor DNA (ctDNA) status with progression in patients
with unresectable stage I-III NSCLC who underwent definitive
nonsurgical treatment. A total of 70 serial plasma samples from 17
NSCLC patients were monitored before, during, and after
conventional radiation with or without concurrent systemic therapy
and adjuvant durvalumab for a median of 26 months.
Key findings include:
- Pre-treatment ctDNA detection rate was 82% (14/17) and varied
based on histology and stage.
- In the longitudinal setting, all patients with clinical
progression had at least one ctDNA-positive result (9/9; 100%
sensitivity), and all progression-free patients were persistently
ctDNA-negative after completing radiation with or without
chemotherapy (8/8; 100% specificity).
- ctDNA detection demonstrated an average lead time of 5.4 months
over clinical progression.
- ctDNA status after radiotherapy (single time point: HR=24.2;
p=0.004), as well as during adjuvant systemic therapy and/or
surveillance (longitudinally; p<0.0001), was highly predictive
of disease progression.
- In a multivariate analysis, ctDNA detection at the first
post-radiation time point was the only significant prognostic
factor associated with progression-free survival (HR: 13.4;
p=0.02).
“This study shows that longitudinal ctDNA monitoring can be a
highly sensitive and specific approach to predicting disease
progression, enabling more customized treatment strategies for
patients with unresectable NSCLC,” said Minetta Liu, MD, chief
medical officer of oncology at Natera. “All patients in the study
cohort who developed clinical progression had detectable ctDNA,
demonstrating the potential of Signatera to identify those at a
high risk of relapse who are likely to benefit from systemic
therapy. These promising findings add to the growing body of
evidence supporting the potential for Signatera to enhance the
quality of care for patients with non-small cell lung cancer.”
This study builds on previous Signatera data across early- and
late-stage NSCLC. This includes the EMPower Lung-1 trial presented
at the 2023 ASCO annual meeting, which demonstrated the ability of
ctDNA to monitor response to immunotherapy and predict clinical
outcomes in advanced NSCLC patients,5 as well as real-world data
presented at the AATS 2023 annual meeting supporting the use of
Signatera to detect progression early in resected, early-stage
NSCLC patients.6 This recent work 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 early-stage NSCLC.7
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test
for treatment monitoring and molecular residual disease (MRD)
assessment in patients previously diagnosed with cancer. The test
is available for both clinical and research use, and has been
granted four Breakthrough Device Designations by the FDA for
multiple cancer types and indications. The Signatera test is
personalized and tumor-informed, providing each individual with a
customized blood test tailored to fit the unique signature of
clonal mutations found in that individual’s tumor. Signatera is
intended to detect and quantify cancer left in the body, at levels
down to a single tumor molecule in a tube of blood, to help
identify recurrence earlier and optimize treatment decisions. The
test has not been cleared or approved by the US Food and Drug
Administration (FDA).
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.
References
- Cancer.Net. Lung Cancer (Non-Small Cell) - Statistics.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
2023.
- Robinson D, Hawthorne S, Zhao, L, et al. Treatment patterns in
non-small-cell lung cancer in USA: results of the CancerMPact
Survey 2018. Future Oncol. 2020 Mar;16(7):255-262.
- Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after
Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. N Engl J
Med. 2017;377:1919-1929.
- Senthi S, Lagerwaard FJ, Haasbeek CJ, et al. Patterns of
disease recurrence after stereotactic ablative radiotherapy for
early stage non-small-cell lung cancer: a retrospective analysis.
Lancet Oncol. 2012;13: 802–809.
- 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.
- Early Real-World Experience Monitoring Circulating Tumor DNA in
Resected Early-Stage Non-Small Cell Lung Cancer. Presented at AATS
Annual Meeting, LA, CA, May 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/20231004918931/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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