Natera to Present New Data at the 2025 ASCO GI Symposium
Natera Inc (NASDAQ: NTRA) announced multiple studies to be presented at the 2025 ASCO GI Symposium in San Francisco. Key highlights include data from the BESPOKE CRC study, the largest prospective MRD study in the U.S., which demonstrated Signatera's effectiveness as a prognostic and predictive biomarker in colorectal cancer patients.
The study showed that Signatera-positive patients had significantly inferior outcomes in both stage II (HR=10.4) and stage III patients (HR=10.1). The 24-month disease-free survival rates were 91.7% for Signatera-negative and 41.4% for Signatera-positive patients.
Additionally, Natera will present initial results from their novel tissue-free MRD detection test, showing high sensitivity and specificity, and early cancer detection data with 95% sensitivity and 91% specificity in colorectal cancer detection. The symposium will feature multiple presentations, including a late-breaking oral presentation on the CALGB/SWOG 80702 study.
Natera Inc (NASDAQ: NTRA) ha annunciato molteplici studi che saranno presentati al 2025 ASCO GI Symposium a San Francisco. Tra i punti salienti vi sono i dati dello studio BESPOKE CRC, il più grande studio prospettico sull'MRD negli Stati Uniti, che ha dimostrato l'efficacia di Signatera come biomarker prognostico e predittivo nei pazienti con cancro colorettale.
Lo studio ha mostrato che i pazienti positivi a Signatera presentavano risultati significativamente inferiori sia nei pazienti di stadio II (HR=10.4) che di stadio III (HR=10.1). I tassi di sopravvivenza libera da malattia a 24 mesi erano del 91,7% per i pazienti negativi a Signatera e del 41,4% per i pazienti positivi a Signatera.
Inoltre, Natera presenterà i risultati iniziali del loro nuovo test di rilevamento dell'MRD senza tessuto, che mostra alta sensibilità e specificità, e dati di rilevamento precoce del cancro con il 95% di sensibilità e il 91% di specificità nella rilevazione del cancro colorettale. Il simposio presenterà diverse relazioni, inclusa una presentazione orale dell'ultima ora sullo studio CALGB/SWOG 80702.
Natera Inc (NASDAQ: NTRA) anunció múltiples estudios que se presentarán en el 2025 ASCO GI Symposium en San Francisco. Los puntos destacados incluyen datos del estudio BESPOKE CRC, el estudio prospectivo de MRD más grande en EE. UU., que demostró la efectividad de Signatera como biomarcador pronóstico y predictivo en pacientes con cáncer colorrectal.
El estudio mostró que los pacientes positivos para Signatera tuvieron resultados significativamente peores tanto en pacientes en estadio II (HR=10.4) como en estadio III (HR=10.1). Las tasas de supervivencia libre de enfermedad a 24 meses fueron del 91.7% para los pacientes negativos a Signatera y del 41.4% para los pacientes positivos a Signatera.
Además, Natera presentará resultados iniciales de su novedosa prueba de detección de MRD sin tejido, mostrando alta sensibilidad y especificidad, y datos de detección temprana de cáncer con un 95% de sensibilidad y un 91% de especificidad en la detección del cáncer colorrectal. El simposio contará con múltiples presentaciones, incluidas una presentación oral de último minuto sobre el estudio CALGB/SWOG 80702.
Natera Inc (NASDAQ: NTRA)은 샌프란시스코에서 열리는 2025 ASCO GI Symposium에서 발표될 여러 연구를 발표했습니다. 주요 하이라이트로는 미국에서 가장 큰 전향적 MRD 연구인 BESPOKE CRC 연구의 데이터가 포함되어 있으며, 이는 대장암 환자에서 Signatera의 예후 및 예측 바이오마커로서의 효과를 입증했습니다.
연구 결과 Signatera 양성 환자는 II기 단계(HR=10.4)와 III기 단계(HR=10.1) 모두에서 결과가 유의미하게 열악함을 보여주었습니다. 24개월 무병 생존율은 Signatera 음성 환자에서 91.7%, Signatera 양성 환자에서 41.4%였습니다.
또한, Natera는 조직이 필요 없는 새로운 MRD 검출 시험의 초기 결과를 발표하며 높은 민감도와 특이성을 보여주었으며, 대장암 감지에서 95%의 민감도와 91%의 특이성을 가진 초기 암 발견 데이터를 제공합니다. 심포지엄에서는 CALGB/SWOG 80702 연구에 대한 마지막 시간 발표를 포함하어 여러 발표가 진행될 예정입니다.
Natera Inc (NASDAQ: NTRA) a annoncé plusieurs études qui seront présentées lors du 2025 ASCO GI Symposium à San Francisco. Les points clés incluent des données de l'étude BESPOKE CRC, la plus grande étude prospective sur le MRD aux États-Unis, qui a démontré l'efficacité de Signatera en tant que biomarqueur pronostique et prédictif chez les patients atteints de cancer colorectal.
L'étude a montré que les patients positifs pour Signatera avaient des résultats significativement inférieurs tant au stade II (HR=10.4) qu'au stade III (HR=10.1). Les taux de survie sans maladie à 24 mois étaient de 91,7 % pour les patients négatifs à Signatera et de 41,4 % pour les patients positifs à Signatera.
De plus, Natera présentera des résultats préliminaires de son nouveau test de détection du MRD sans tissu, montrant une grande sensibilité et spécificité, ainsi que des données de détection précoce du cancer avec 95 % de sensibilité et 91 % de spécificité dans la détection du cancer colorectal. Le symposium comprendra plusieurs présentations, y compris une présentation orale de dernière minute sur l'étude CALGB/SWOG 80702.
Natera Inc (NASDAQ: NTRA) hat mehrere Studien angekündigt, die beim 2025 ASCO GI Symposium in San Francisco vorgestellt werden. Zu den wichtigsten Punkten gehören Daten aus der BESPOKE CRC-Studie, der größten prospektiven MRD-Studie in den USA, die die Wirksamkeit von Signatera als prognostischen und prädiktiven Biomarker bei Patienten mit Kolorektalkrebs nachgewiesen hat.
Die Studie zeigte, dass Signatera-positive Patienten sowohl in der Stadium-II-Gruppe (HR=10.4) als auch in der Stadium-III-Gruppe (HR=10.1) signifikant schlechtere Ergebnisse erzielten. Die 24-monatige krankheitsfreie Überlebensrate betrug 91,7 % für Signatera-negative und 41,4 % für Signatera-positive Patienten.
Darüber hinaus wird Natera erste Ergebnisse aus ihrem neuartigen gewebefreien MRD-Nachweistest präsentieren, der hohe Sensitivität und Spezifität zeigt, sowie frühe Krebsnachweisdaten mit 95 % Sensitivität und 91 % Spezifität bei der Kolorektalkrebsdiagnose. Das Symposium wird mehrere Präsentationen umfassen, einschließlich einer kurzfristigen mündlichen Präsentation zur CALGB/SWOG 80702-Studie.
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First set of abstracts released include Signatera™ data from BESPOKE CRC, the largest prospective, observational, multicenter MRD study in the
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
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
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
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
“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.
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
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
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
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.
View source 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
Source: Natera, Inc.
FAQ
What were the key findings of Natera's BESPOKE CRC study presented at ASCO GI 2025?
What accuracy rates did Natera's new tissue-free MRD test demonstrate?
How effective is Natera's early cancer detection test for colorectal cancer?
What is the significance of Signatera results for treatment decisions in NTRA's BESPOKE CRC study?
