Natera Announces Three New Signatera Publications; Includes Groundbreaking Overall Survival Data Published in Nature Medicine and also Released at ESMO
Natera (NASDAQ: NTRA) announced three new peer-reviewed publications for its Signatera test, surpassing 85 total publications. Key highlights include:
1. Colorectal cancer (CRC) data from the GALAXY arm of CIRCULATE-Japan, published in Nature Medicine and presented at ESMO 2024, showing Signatera's ability to predict overall survival and adjuvant chemotherapy benefit.
2. Additional CRC data from GALAXY, published in Annals of Oncology, demonstrating Signatera's ability to risk-stratify patients after liver metastases resection.
3. Breast cancer data from the BELLINI trial, published in Nature Medicine, exploring immune checkpoint inhibitors without chemotherapy in triple-negative breast cancer, with Signatera showing correlation to treatment response.
Natera (NASDAQ: NTRA) ha annunciato tre nuove pubblicazioni revisionate da esperti per il suo test Signatera, superando le 85 pubblicazioni totali. I punti salienti includono:
1. Dati sul cancro colorettale (CRC) dall'arm GALAXY di CIRCULATE-Japan, pubblicati su Nature Medicine e presentati all'ESMO 2024, che mostrano la capacità di Signatera di prevedere la sopravvivenza complessiva e il beneficio della chemioterapia adiuvante.
2. Ulteriori dati sul CRC da GALAXY, pubblicati nelle Annals of Oncology, che dimostrano la capacità di Signatera di stratificare il rischio dei pazienti dopo la resezione delle metastasi epatiche.
3. Dati sul cancro al seno dal trial BELLINI, pubblicati su Nature Medicine, che esplorano gli inibitori dei checkpoint immunitari senza chemioterapia nel cancro al seno triplo negativo, con Signatera che mostra una correlazione alla risposta al trattamento.
Natera (NASDAQ: NTRA) anunció tres nuevas publicaciones revisadas por pares para su prueba Signatera, superando un total de 85 publicaciones. Los aspectos más importantes incluyen:
1. Datos sobre cáncer colorrectal (CRC) del brazo GALAXY de CIRCULATE-Japan, publicados en Nature Medicine y presentados en ESMO 2024, que muestran la capacidad de Signatera para predecir la supervivencia general y el beneficio de la quimioterapia adyuvante.
2. Datos adicionales de CRC de GALAXY, publicados en Annals of Oncology, que demuestran la capacidad de Signatera para estratificar el riesgo de los pacientes después de la resección de metástasis hepáticas.
3. Datos sobre cáncer de mama del ensayo BELLINI, publicados en Nature Medicine, que exploran los inhibidores de puntos de control inmunitarios sin quimioterapia en el cáncer de mama triple negativo, mostrando Signatera una correlación con la respuesta al tratamiento.
Natera (NASDAQ: NTRA)는 Signatera 테스트를 위한 세 개의 새로운 동료 검토 출판물을 발표하며 총 85개의 출판물을 초과했습니다. 주요 하이라이트는 다음과 같습니다:
1. CIRCULATE-Japan의 GALAXY 팔에서 나온 대장암 (CRC) 데이터가 Nature Medicine에 발표되었고 ESMO 2024에서 발표되어 Signatera가 전체 생존율과 보조 화학 요법의 이점을 예측할 수 있는 능력을 보여줍니다.
2. GALAXY에서 나온 추가 CRC 데이터가 Annals of Oncology에 발표되어 Signatera가 간 전이 절제 후 환자를 위험 분류할 수 있는 능력을 입증합니다.
3. BELLINI 시험에서 얻은 유방암 데이터가 Nature Medicine에 발표되어 삼중 음성 유방암에서 화학 요법 없이 면역 체크포인트 억제제를 탐색하고 Signatera가 치료 반응과의 상관관계를 보여줍니다.
Natera (NASDAQ: NTRA) a annoncé trois nouvelles publications évaluées par des pairs pour son test Signatera, dépassant ainsi les 85 publications au total. Les points clés incluent :
1. Des données sur le cancer colorectal (CRC) provenant du bras GALAXY de CIRCULATE-Japan, publiées dans Nature Medicine et présentées à l'ESMO 2024, montrant la capacité de Signatera à prédire la survie globale et le bénéfice de la chimiothérapie adjuvante.
2. Données supplémentaires sur le CRC provenant de GALAXY, publiées dans les Annals of Oncology, démontrant la capacité de Signatera à stratifier le risque des patients après la résection de métastases hépatiques.
3. Des données sur le cancer du sein provenant de l'essai BELLINI, publiées dans Nature Medicine, explorant les inhibiteurs des points de contrôle immunitaires sans chimiothérapie dans le cancer du sein triple négatif, avec Signatera montrant une corrélation avec la réponse au traitement.
Natera (NASDAQ: NTRA) hat drei neue peer-reviewed Publikationen für seinen Signatera-Test angekündigt und damit die Gesamtzahl von 85 Publikationen überschritten. Die wichtigsten Punkte sind:
1. Daten zum kolorektalen Krebs (CRC) aus dem GALAXY-Arm von CIRCULATE-Japan, veröffentlicht in Nature Medicine und präsentiert auf der ESMO 2024, die die Fähigkeit von Signatera zeigen, das Gesamtüberleben und den Nutzen einer adjuvanten Chemotherapie vorherzusagen.
2. Zusätzliche CRC-Daten aus GALAXY, veröffentlicht in den Annals of Oncology, die die Fähigkeit von Signatera demonstrieren, Patienten nach der Resektion von Lebermetastasen zu risikostratifizieren.
3. Daten zu Brustkrebs aus der BELLINI-Studie, veröffentlicht in Nature Medicine, die Immun-Checkpoint-Inhibitoren ohne Chemotherapie bei triple-negativem Brustkrebs untersuchen, wobei Signatera eine Korrelation zur Therapieantwort zeigt.
- Signatera test surpassed 85 peer-reviewed publications, demonstrating strong clinical validation
- GALAXY study (2,240 CRC patients) showed Signatera predicts overall survival and adjuvant chemotherapy benefit
- Signatera effectively risk-stratified CRC patients after liver metastases resection
- BELLINI trial showed Signatera's ability to correlate with treatment response in triple-negative breast cancer
- None.
Insights
The publication of three peer-reviewed papers on Natera's Signatera test is a significant milestone, potentially boosting investor confidence in the company's scientific credibility. With over 85 peer-reviewed publications, Signatera's clinical validation across multiple cancer types strengthens Natera's position in the competitive liquid biopsy market.
The groundbreaking colorectal cancer data from the GALAXY trial, published in Nature Medicine, is particularly noteworthy. The study's large scale (2,240 patients) and its ability to predict overall survival and adjuvant chemotherapy benefit could lead to increased adoption of Signatera in clinical practice. This may translate to higher test volumes and revenue growth for Natera in the coming quarters.
While the immediate financial impact is not quantified, these publications could accelerate market penetration and payer coverage for Signatera, potentially driving long-term value for shareholders. Investors should monitor upcoming earnings reports for signs of increased test adoption and revenue growth resulting from these scientific advancements.
The simultaneous publication of three Signatera studies in prestigious journals like Nature Medicine and Annals of Oncology significantly enhances the test's clinical utility. The GALAXY trial's results are particularly impactful, demonstrating Signatera's ability to predict overall survival in colorectal cancer patients – a important endpoint in oncology.
The data showing Signatera's capacity to identify patients who benefit from adjuvant chemotherapy could lead to more personalized treatment decisions, potentially reducing unnecessary treatments and improving patient outcomes. This aligns with the growing trend towards precision oncology.
The BELLINI trial results in triple-negative breast cancer are also promising, showing Signatera's potential in monitoring response to immunotherapy. As immunotherapies become increasingly important in cancer treatment, tools like Signatera that can track treatment efficacy could become invaluable in clinical practice.
The publication of these studies marks a significant advancement in the field of liquid biopsy and molecular residual disease (MRD) detection. The GALAXY trial's large cohort (2,240 patients) and median follow-up of 23 months provide robust evidence for Signatera's clinical utility in colorectal cancer management.
The ability to predict overall survival and adjuvant chemotherapy benefit could position Signatera as a standard of care in post-surgical monitoring of colorectal cancer patients. This could lead to changes in clinical guidelines and practice patterns, potentially expanding Natera's market share.
The BELLINI trial results also highlight Signatera's versatility across different cancer types and treatment modalities. As more data accumulates, Signatera could become a valuable tool in the broader oncology landscape, opening up new market opportunities for Natera beyond its current indications.
Signatera now has >85 peer-reviewed publications with clinical validation across multiple cancer types and indications
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Groundbreaking colorectal cancer (CRC) data from the GALAXY arm of the ongoing CIRCULATE-Japan trial, published today in Nature Medicine, and also available in Poster Presentation #553P at the 2024 Congress of the European Society for Medical Oncology (ESMO) in
Barcelona, Spain . - Additional CRC data from GALAXY, published today in Annals of Oncology, and also available in Poster Presentation #558P at ESMO.
- A new paper from the BELLINI trial, published today in Nature Medicine, investigating the feasibility and potential efficacy of immune checkpoint inhibitors (ICI) without concurrent chemotherapy in triple negative breast cancer (TNBC).
CRC Data from GALAXY (Nature Medicine & ESMO Poster)
In this study, 2,240 patients with stage II– IV CRC were monitored using Signatera after curative-intent surgery with a median follow-up of 23 months. This data provides the first evidence of Signatera-based molecular residual disease (MRD) detection to predict overall survival (OS) and highlights Signatera’s ability to predict adjuvant chemotherapy (ACT) benefit. Full details on the data are available here, as announced on Sept. 14, 2024.
CRC Data from GALAXY (Annals of Oncology & ESMO Poster)
This study retrospectively analyzed 190 patients enrolled in GALAXY who underwent surgical resection for colorectal liver metastases and underscores Signatera’s ability to risk-stratify CRC patients. Of the patients who were Signatera-positive within 2-10 weeks after surgical resection, 24-month disease free survival (DFS) was superior for those who received ACT compared to patients on observation, whereas no statistically significant benefit of ACT was observed among Signatera-negative patients.
Breast Cancer Data from Bellini Trial (Nature Medicine)
This study reports initial results from the BELLINI trial, a phase 2 study that enrolled 43 patients with stage I-III triple-negative breast cancer (TNBC). Patients in the study underwent short-term (2-3 cycles) of nivolumab, alone or in combination with ipilimumab, prior to standard-of-care neoadjuvant chemotherapy or surgery. Circulating tumor DNA (ctDNA) analysis with Signatera was performed before treatment and after 4 or 6 weeks of treatment. All clinical responders including patients who achieved pathologic complete response demonstrated at least a
“We are extremely proud to announce the publication of these datasets in top-tier medical journals, underscoring the breadth of clinical evidence we continue to build on the utility of Signatera,” said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. “The first overall survival readout in colorectal cancer from GALAXY marks a landmark moment that may fundamentally change how resectable colorectal cancer is managed for the hundreds of thousands of patients at risk of recurrence each year. We are especially grateful to the patients who participated in these trials, as well as our collaborators and study investigators for their dedication to improving outcomes for 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 85 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.
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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 the GALAXY study for Natera's Signatera test in colorectal cancer?
How did Natera's Signatera perform in the BELLINI trial for triple-negative breast cancer?
What milestone did Natera's Signatera test reach in terms of peer-reviewed publications?
How did Natera's Signatera test perform in risk-stratifying colorectal cancer patients after liver metastases resection?
