Natera to Present New Signatera™ Colorectal Cancer Data at ESMO Showing 10X Advantage in Overall Survival
Natera will present new data on its Signatera molecular residual disease (MRD) test at the 2024 ESMO Congress. Key highlights include:
1. Data from the GALAXY arm of CIRCULATE-Japan trial, showing Signatera-positive patients had significantly shorter overall survival (OS) compared to Signatera-negative patients (hazard ratio ~10).
2. First prospective read-out of OS based on MRD in colorectal cancer (CRC).
3. New data on adjuvant chemotherapy (ACT) benefit in Signatera-positive and negative patients.
4. Additional presentations on Signatera in breast cancer and squamous cell carcinoma of the head and neck.
These findings underscore Signatera's potential to predict long-term outcomes and guide treatment decisions in early-stage CRC.
Natera presenterà nuovi dati sul suo test di malattia residua molecolare (MRD) Signatera al Congresso ESMO 2024. I punti salienti includono:
1. Dati dal braccio GALAXY della sperimentazione CIRCULATE-Japan, che mostrano come i pazienti risultati positivi al test Signatera abbiano avuto una sopravvivenza globale (OS) significativamente più breve rispetto ai pazienti negativi (rapporto di rischio ~10).
2. Prima lettura prospettica della sopravvivenza globale basata sul MRD nel cancro colorettale (CRC).
3. Nuovi dati sui benefici della chemioterapia adiuvante (ACT) in pazienti positivi e negativi al test Signatera.
4. Presentazioni aggiuntive su Signatera nel cancro al seno e nel carcinoma a cellule squamose della testa e del collo.
Questi risultati sottolineano il potenziale di Signatera nel prevedere esiti a lungo termine e nel guidare le decisioni terapeutiche nel CRC in fase iniziale.
Natera presentará nuevos datos sobre su prueba de enfermedad residual molecular (MRD) Signatera en el Congreso ESMO 2024. Los puntos destacados incluyen:
1. Datos del brazo GALAXY del ensayo CIRCULATE-Japan, que muestran que los pacientes positivos en Signatera tuvieron una supervivencia global (OS) significativamente más corta en comparación con los pacientes negativos (razón de peligro ~10).
2. Primer resultado prospectivo de OS basado en MRD en cáncer colorrectal (CRC).
3. Nuevos datos sobre el beneficio de la quimioterapia adyuvante (ACT) en pacientes positivos y negativos de Signatera.
4. Presentaciones adicionales sobre Signatera en cáncer de mama y carcinoma de células escamosas de cabeza y cuello.
Estos hallazgos subrayan el potencial de Signatera para predecir resultados a largo plazo y guiar las decisiones de tratamiento en el CRC en etapa temprana.
Natera는 2024 ESMO Congress에서 Signatera 분자 잔여 질환(MRD) 시험에 대한 새로운 데이터를 발표할 예정이다. 주요 결과는 다음과 같다:
1. GALAXY arms of CIRCULATE-Japan trial의 데이터로, Signatera 양성 환자들이 Signatera 음성 환자들에 비해 전체 생존율(OS)이 유의미하게 짧았다는 것을 보여준다(위험 비율 ~10).
2. 대장암(CRC)의 MRD를 기반으로 한 OS의 첫 번째 전향적 결과 읽기.
3. Signatera 양성 및 음성 환자에서 보조 화학요법(ACT) 혜택에 대한 새로운 데이터.
4. 유방암 및 두경부 편평세포암에서 Signatera에 대한 추가 발표.
이러한 발견은 Signatera의 잠재력이 초기 대장암에서 장기적인 결과를 예측하고 치료 결정을 안내할 수 있음을 강조한다.
Natera présentera de nouvelles données sur son test de maladie résiduelle moléculaire (MRD) Signatera lors du Congrès ESMO 2024. Les points clés comprennent :
1. Données du bras GALAXY de l'essai CIRCULATE-Japan, montrant que les patients positifs au test Signatera avaient une survie globale (OS) significativement plus courte par rapport aux patients négatifs (rapport de risque ~10).
2. Première évaluation prospective de l'OS basée sur le MRD dans le cancer colorectal (CRC).
3. Nouvelles données sur les bénéfices de la chimiothérapie adjuvante (ACT) chez les patients positifs et négatifs au test Signatera.
4. Présentations supplémentaires sur Signatera dans le cancer du sein et le carcinome à cellules squameuses de la tête et du cou.
Ces résultats soulignent le potentiel de Signatera à prédire les résultats à long terme et à guider les décisions de traitement dans le CRC à un stade précoce.
Natera wird neue Daten zu seinem Signatera Test für molekulare Resterkrankung (MRD) auf dem ESMO Kongress 2024 präsentieren. Zu den wichtigsten Punkten gehören:
1. Daten aus dem GALAXY-Arm der CIRCULATE-Japan Studie, die zeigen, dass Signatera-positive Patienten eine signifikant kürzere Gesamtüberlebenszeit (OS) im Vergleich zu Signatera-negativen Patienten hatten (Hazard Ratio ~10).
2. Erste prospektive Auswertung der OS basierend auf MRD bei kolorektalem Krebs (CRC).
3. Neue Daten zu den Vorteilen der adjuvanten Chemotherapie (ACT) bei Signatera-positiven und negativen Patienten.
4. Weiterführende Präsentationen zu Signatera bei Brustkrebs und Plattenepithelkarzinomen des Kopfes und Halses.
Diese Ergebnisse heben das Potenzial von Signatera hervor, langfristige Ergebnisse vorhersagen und Therapieentscheidungen im frühen Stadium des CRC leiten zu können.
- None.
- None.
Presentations include abstracts from the GALAXY arm of the CIRCULATE-Japan trial, along with new data in Breast Cancer and Squamous Cell Carcinoma of the Head and Neck
Natera and its collaborators will present a total of nine abstracts, including five poster presentations from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC).
The GALAXY data includes an updated analysis of more than 2,100 patients with stage I-IV CRC, reporting 36-month disease-free survival (DFS), and, for the first time, overall survival (OS). Key highlights include:
- Signatera-positive patients had significantly shorter OS compared to those who were Signatera-negative (hazard ratio of ~10), suggesting that Signatera-negative patients had an almost 10-fold advantage in OS. This compares favorably to all known guideline recommended biomarkers that typically have hazard ratios for overall survival in the 1-4 range.
-
Overall survival stratified by adjuvant chemotherapy (ACT) will also be presented. This will build on prior GALAXY DFS data which has shown significant benefit of ACT in Signatera-positive patients, but lack of benefit in Signatera-negative patients. The current standard of care is based on studies showing that most CRC patients derive a small ~0
-5% absolute and ~10-20% relative OS benefit from ACT. Identifying subgroups where this benefit is concentrated is critical for advancing clinical management of early-stage CRC.
“ESMO 2024 will showcase some of our most impactful data in colorectal cancer to-date,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Notably, we will present an updated analysis from the GALAXY arm of CIRCULATE-Japan with the first prospective read-out of overall survival based on MRD. These findings underscore the potential for Signatera to predict long-term outcomes.”
Other presentations at ESMO will highlight new Signatera data in breast cancer and squamous cell carcinoma of the head and neck. Below is the full list of presentations:
Presentation Highlights
Poster Presentation #553P | CRC | Sept. 16 | Presenter: Jun Nagata, MD
Association of ctDNA-based MRD detection and MRD clearance with short-term overall survival in patients with resectable colorectal cancer: Updated analysis of CIRCULATE-Japan GALAXY
Poster Presentation #558P | CRC | Sept. 16 | Presenter: Kozo Kataoka, MD, PhD
Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases; subgroup analysis from CIRCULATE-Japan GALAXY
Oral Presentation and Additional Presentations
Oral Presentation | CRC | Presenter: Myriam Chalabi, MD
Sept. 15, 09:10 - 09:20
Neoadjuvant immunotherapy in locally advanced MMR-deficient (dMMR) colon cancer (CC): 3-year disease-free survival (DFS) from NICHE-2
Poster Presentation #923P | SCCHN | Sept. 14 | Presenter: Natasha Honoré, MD, PhD
Tumor-informed ctDNA assay to predict recurrence in locally advanced SCCHN
Poster Presentation #555P | CRC | Sept. 16 | Presenter: Tomoya Harima, MD
Association Between Copy Number Aberration and ctDNA MRD in Colorectal Cancer: CIRCULATE-Japan GALAXY
Poster Presentation #554P | CRC | Sept. 16 | Presenter: Yoshiaki Nakamura, MD, PhD
Novel Clinical Decision Support (CDS) System Optimizing Adjuvant Chemotherapy (ACT) for Colorectal Cancer (CRC) by Integrating Deep Learning and circulating tumor DNA (ctDNA) molecular residual disease (MRD): GALAXY Histotyping
Poster Presentation #545P | CRC | Sept. 16 | Presenter: Chiara M. Loeffler, MD
HIBRID: Histology and ct-DNA based Risk-stratification with Deep Learning
Poster Presentation #338TiP | Breast Cancer | Sept. 16 | Presenter: Michail Ignatiadis, MD, PhD
EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)
Poster Presentation #314P | Breast Cancer | Sept. 16 | Presenter: Mark Magbanua, PhD
The impact of changes in tumor mutational landscape during neoadjuvant therapy on tumor-informed ctDNA testing in breast cancer patients
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 more than 70 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 200 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/20240908441735/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 is the significance of the Signatera test's hazard ratio for overall survival in colorectal cancer patients?
How many patients were included in the GALAXY arm of the CIRCULATE-Japan trial for Natera's NTRA stock?
What new data will Natera (NTRA) present on Signatera at ESMO 2024 for colorectal cancer patients?
How many abstracts will Natera (NTRA) present at the 2024 ESMO Congress?
What other cancer types will Natera (NTRA) present Signatera data on at ESMO 2024?
