First set of abstracts released include
Signatera™ data from BESPOKE CRC, the largest prospective,
observational, multicenter MRD study in the U.S. to date, along
with the first read-outs in early cancer detection and tissue-free
MRD
Additional Signatera data will be shared at
ASCO GI on Jan. 25, 2025, including a late-breaking oral
presentation on the CALGB (Alliance) / SWOG 80702 study
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
and genetic testing, today announced that the first set of
abstracts have been released from several studies that will be
shared at the American Society of Clinical Oncology’s
Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 –
25, 2025 in San Francisco, CA.
BESPOKE CRC Study
New data will be presented in an oral presentation on Jan. 25
from BESPOKE CRC, a multicenter, prospective, observational study
in colorectal cancer (CRC). The study underscores Signatera’s
capability as a prognostic and a predictive biomarker in a cohort
of over 1,000 patients wherein post-surgical Signatera-positivity
was predictive of inferior outcomes in stage II patients
[disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III
patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages
II-III combined were 91.7% for Signatera-negative and 41.4% for
Signatera-positive. Signatera-positive patients benefitted from
adjuvant treatment while Signatera-negative patients did not, and
clearance of ctDNA during and after treatment led to superior DFS
outcomes.
Additional data from the study will be shared during the
symposium illustrating the impact of MRD detection on clinical
decision-making. The data show that even in the early days of MRD
commercialization, a significant number of oncologists escalated or
de-escalated post-surgical chemotherapy plans based on Signatera
results, and the vast majority of oncologists found that Signatera
results strengthened the treatment plan under consideration. In
addition, surveillance with Signatera enabled a high rate of
curative-intent surgery among recurrent patients.
Readouts in Tissue-Free MRD and Early
Cancer Detection
Initial results from a clinical performance study on Natera’s
novel tissue-free MRD detection test will be presented, where high
sensitivity and specificity were observed in patients evaluable for
clinical outcomes. The study demonstrated that the tissue-free MRD
assay was prognostic, with MRD-positive patients showing inferior
recurrence-free survival. The data also showed that the test was
predictive, as MRD-positive patients benefited from adjuvant
therapy whereas MRD-negative patients did not. In addition, the
data showed strong concordance between the tissue-free MRD test and
the gold standard Signatera test, with a positive percent agreement
of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95%
CI: 95-100%).
Natera will also present case-control data in early cancer
detection, including data from screen-detected colorectal cancer
cases from the CIRCULATE study and controls from the PROCEED-CRC
study, respectively. The data reports an overall sensitivity of 95%
(95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among
patients with stage I disease, sensitivity was 92% overall.
Stage-adjusted sensitivity was 91% in screen-detected
individuals.
“This data at ASCO GI demonstrates the ongoing strength of
Signatera complemented by our exciting innovation pipeline,” said
Adham Jurdi, MD, senior medical director in oncology at Natera.
“The results from BESPOKE CRC highlight the potential value of
Signatera-based MRD detection for treatment-decision making, with
strong findings in clinical utility. Our readouts in early cancer
detection and tissue-free MRD offer great promise for expanding
Natera’s portfolio to help millions of additional patients with
cancer.”
Full list of Signatera presentations
and activities during ASCO GI
Oral Presentations
Jan. 25, 1:00 PM PT | Abstract # 15 |
Stage II-III Colorectal Cancer (Oral Presentation) Presenter:
Purvi K. Shah, MD, MBBS, Virginia Cancer Institute Circulating
Tumor DNA for Detection of Molecular Residual Disease (MRD) in
Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final
Analysis of the BESPOKE CRC sub cohort
Jan. 25, 1:00 PM PT | Abstract # LBA14 |
Colon Cancer (Oral Presentation) Presenter: Jonathan A. Nowak,
MD, PhD, Brigham and Women's Hospital Prognostic and predictive
role of circulating tumor DNA (ctDNA) in stage III colon cancer
treated with celecoxib: Findings from CALGB (Alliance)/SWOG
80702
Posters
Jan. 23, 11:30 AM PT | Abstract # TPS512 |
Gastroesophageal adenocarcinoma (Poster) Presenter: Elizabeth
Catherine Smyth, MD, Oxford University Hospitals NHS Foundation
Trust A single arm phase II trial of trastuzumab deruxtecan in
patients with gastroesophageal adenocarcinoma cancer who are ctDNA
and HER2 posiative: DECIPHER
Jan. 23, 11:30 AM PT | Abstract # 836 |
Gastrointestinal cancers (Poster) Presenter: Sakti Chakrabarti,
MD, University Hospitals Seidman Cancer Center, Case Comprehensive
Cancer Center Short interval circulating tumor DNA (ctDNA) kinetics
as a predictor of tumor response in patients with gastrointestinal
(GI) cancer receiving immune checkpoint inhibitor (ICI)-based
treatment
Jan. 25, 7:00 AM PT | Abstract # 266 |
Tissue-free MRD testing (Poster) Presenter: John Paul Y.C.
Shen, MD, University of Texas MD Anderson Cancer Center Development
of a methylation-based, tissue-agnostic test for the detection of
molecular residual disease by circulating tumor DNA
Jan. 25, 7:00 AM PT | Abstract # 232 |
Early cancer detection: colorectal cancer (Poster) Presenter:
Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and
Gastrointestinal Oncology, National Cancer Center Hospital East
Performance of a blood-based screening test for the early detection
of colorectal cancer
Jan. 25, 7:00 AM PT | Abstract # TPS306 |
Early cancer detection: Trial in Progress (Poster) Presenter:
Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin,
TX, USA Trial in progress for a colorectal cancer detection blood
test
Jan. 25, 7:00 AM PT | Abstract # LBA 22 |
Colorectal cancer (Poster) Presenter: Hideaki Bando, MD,
National Cancer Center Hospital Japan A Randomized, Double-Blind,
Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus
Placebo in Patients with Molecular Residual Disease Following
Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study
Jan. 25, 7:00 AM PT | Abstract # 220 |
Metastatic colorectal cancer (Poster) Presenter: D.E. van
Steijn, MSc, Netherlands Cancer Institute Longitudinal ctDNA
measurements for treatment response monitoring in patients with
metastatic colorectal cancer undergoing systemic therapy: The ORCA
trial
Jan. 25, 7:00 AM PT | Abstract # 284 |
Locally advanced rectal cancer (Poster) Presenter: Jun
Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical
University Circulating tumor DNA for predicting complete response
to total neoadjuvant therapy in locally advanced rectal cancer:
ENSEMBLE-2
Jan 25, 7:00 AM PT | Abstract # 263 |
Rectal adenocarcinoma (Poster) Presenter: Seth Felder, MD, H.
Lee Moffitt Cancer Center Correlation of mid-chemoradiation ctDNA
results and clinical complete response to total neoadjuvant therapy
(TNT) for locally advanced rectal adenocarcinoma
Jan 25, 7:00 AM PT | Abstract # 48 |
Colorectal cancer (Poster) Presenter: Elisabeth Arrondo, BSc,
Translational Research Support Office, National Cancer Center
Hospital East Molecular characteristics and prognostic impact of
GNAS mutation in colorectal cancer: An international collaborative
study between United States and Japan
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 over 100 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 250 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/20250121322128/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
Natera (NASDAQ:NTRA)
過去 株価チャート
から 12 2024 まで 1 2025
Natera (NASDAQ:NTRA)
過去 株価チャート
から 1 2024 まで 1 2025
