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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Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]