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Natera (NASDAQ: NTRA) announced its upcoming presentation of new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), December 10-13. The company will present six abstracts, including significant findings from the ZEST clinical trial, which showed improved disease-free survival with niraparib treatment in ctDNA-positive breast cancer patients (11.4 months vs 5.4 months for placebo).
Key highlights include a clinical genomics study revealing 44% of Signatera-positive patients had targetable genomic alterations, with 34.5% showing PIK3CA mutations. Additionally, four abstracts will present patient-reported outcomes indicating that ctDNA testing provides valuable treatment planning information without increasing patient anxiety.
Natera (NASDAQ: NTRA) ha annunciato la sua prossima presentazione di nuovi dati SignateraTM al San Antonio Breast Cancer Symposium (SABCS), dal 10 al 13 dicembre. L’azienda presenterà sei abstract, comprese scoperte significative dal trial clinico ZEST, che ha mostrato un miglioramento della sopravvivenza libera da malattia con il trattamento con niraparib nei pazienti con cancro al seno positivi al ctDNA (11,4 mesi contro 5,4 mesi per il placebo).
Tra i punti salienti vi è uno studio di genomica clinica che ha rivelato che il 44% dei pazienti positivi a Signatera presentava alterazioni genomiche trattabili, con il 34,5% che mostrava mutazioni PIK3CA. Inoltre, quattro abstract presenteranno risultati riferiti dai pazienti che indicano che il test ctDNA fornisce informazioni preziose per la pianificazione del trattamento senza aumentare l’ansia dei pazienti.
Natera (NASDAQ: NTRA) anunció su próxima presentación de nuevos datos SignateraTM en el Simposio sobre el Cáncer de Mama de San Antonio (SABCS), del 10 al 13 de diciembre. La compañía presentará seis resúmenes, incluyendo hallazgos significativos del ensayo clínico ZEST, que mostró una mejora en la supervivencia libre de enfermedad con el tratamiento de niraparib en pacientes con cáncer de mama positivo para ctDNA (11,4 meses frente a 5,4 meses para el placebo).
Los aspectos más destacados incluyen un estudio de genómica clínica que revela que el 44% de los pacientes positivos para Signatera tenían alteraciones genómicas tratables, con un 34,5% mostrando mutaciones en PIK3CA. Además, cuatro resúmenes presentarán resultados informados por los pacientes que indican que la prueba de ctDNA proporciona información valiosa para la planificación del tratamiento sin aumentar la ansiedad del paciente.
네이테라(NASDAQ: NTRA)가 12월 10일부터 13일까지 열리는 샌안토니오 유방암 심포지엄(SABCS)에서 새로운 SignateraTM 데이터 발표를 예고했습니다. 회사는 ZEST 임상 시험의 중요한 발견을 포함하여 여섯 건의 초록을 발표할 예정이며, 이 시험은 ctDNA 양성 유방암 환자에서 니라파립 치료가 질병 무진행 생존 기간을 향상시켰음을 보여주었습니다(11.4개월 대 위약의 5.4개월).
주요 하이라이트는 44%의 Signatera 양성 환자가 표적 유전자 변이를 가지고 있었으며, 그 중 34.5%가 PIK3CA 변이를 보였다는 임상 유전학 연구 결과를 포함합니다. 또한, 네 개의 초록이 ctDNA 검사가 환자의 불안을 증가시키지 않으면서 유용한 치료 계획 정보를 제공한다는 환자 보고 결과를 발표할 것입니다.
Natera (NASDAQ: NTRA) a annoncé sa prochaine présentation de nouvelles données SignateraTM au San Antonio Breast Cancer Symposium (SABCS), qui aura lieu du 10 au 13 décembre. L’entreprise présentera six résumés, y compris des résultats significatifs de l’, qui a montré une amélioration de la survie sans maladie avec le traitement par niraparib chez les patientes atteintes de cancer du sein positives au ctDNA (11,4 mois contre 5,4 mois pour le placebo).
Les points clés incluent une étude de génomique clinique révélant que 44 % des patientes positives au Signatera présentaient des altérations génomiques ciblables, avec 34,5 % montrant des mutations dans PIK3CA. De plus, quatre résumés présenteront des résultats rapportés par les patientes, indiquant que le test ctDNA fournit des informations précieuses pour la planification du traitement sans augmenter l’anxiété des patientes.
Natera (NASDAQ: NTRA) hat die bevorstehende Präsentation neuer SignateraTM-Daten beim San Antonio Breast Cancer Symposium (SABCS) vom 10. bis 13. Dezember angekündigt. Das Unternehmen wird sechs Abstracts präsentieren, darunter wichtige Ergebnisse aus der ZEST-Studie, die eine verbesserte krankheitsfreie Überlebenszeit bei der Behandlung mit Niraparib bei ctDNA-positiven Brustkrebspatienten zeigt (11,4 Monate versus 5,4 Monate für das Placebo).
Zu den wichtigsten Erkenntnissen gehört eine klinische Genomikstudie, die zeigt, dass 44% der Signatera-positiven Patienten ansprechbare genomische Veränderungen aufwiesen, wobei 34,5% PIK3CA-Mutationen zeigten. Darüber hinaus werden vier Abstracts Ergebnisse präsentieren, die von Patienten gemeldet wurden und darauf hinweisen, dass ctDNA-Tests wertvolle Informationen für die Behandlungsplanung bieten, ohne die Angst der Patienten zu erhöhen.
AUSTIN, Texas–(BUSINESS WIRE)– Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that it will present new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 10-13 in San Antonio, TX. Natera and its collaborators will present a total of six abstracts.
“We are proud to share this new data on Signatera at SABCS that underscores our commitment to generating evidence on the clinical utility of Signatera for patients with breast cancer,” said Angel Rodriguez, M.D., senior medical director at Natera.
The full list of abstracts with selected highlights are as follows:
ZEST Clinical Trial
Oral Presentation #GS3-01 | Dec. 13 | Presenter: Nicholas Turner, MD, PhD, FRCP, FMedSci
Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients with triple-negative breast cancer or HR+ HER2− BRCA-mutated breast cancer with molecular residual disease after definitive therapy
ZEST was a randomized, phase III, double-blind trial, sponsored by GSK, that evaluated whether niraparib can enhance disease-free survival in patients with breast cancer who are ctDNA-positive after completion of curative intent therapy and without evidence of radiographic recurrence. A total of 2,746 patients were pre-screened. Of patients who were ctDNA-positive, 40 were enrolled and randomized (niraparib, 18; placebo, 22); 36 patients (90%) had Triple Negative Breast Cancer (TNBC), and 4 patients (10%) had BRCA-mutated HR+ disease. An analysis of outcomes among randomized patients showed a median disease-free survival of 11.4 months in the niraparib arm versus 5.4 months in the placebo group (hazard ratio, 0.64; 95% CI, 0.30–1.39).
Clinical Genomics Database Experience
Poster Spotlight #PS9-01 | Dec. 12 | Presenter: Marla Lipsyc-Sharf, MD
Actionable Genomic Alterations in Localized Hormone Receptor Positive (HR+) Breast Cancer and Impact on Clinical Outcomes: Results from Comprehensive Whole Exome Sequencing (WES) and Tumor-Informed circulating tumor DNA (ctDNA) analysis
This real-world analysis evaluated the association of targetable tumor genomic alterations with ctDNA detection and distant recurrence-free survival (DRFS) in early-stage breast cancer. In the study, 44% of patients (127/287) who were Signatera-positive had at least one targetable genomic alternation, including 34.5% with the PIK3CA mutation. In addition, of patients with ctDNA-positivity within 2 years, those with mutated PIK3CA had an inferior DRFS (HR: 36.9), compared to patients with wild-type PIK3CA (HR=16.3).
Patient-Reported Outcomes
Four abstracts to be presented at SABCS evaluated patient reported outcomes when testing for circulating tumor DNA (ctDNA). The data indicates that ctDNA testing can provide valuable information for treatment planning while not causing increased anxiety in patients.
Poster #P2-03-21 | Dec. 11 | Presenter: Neil Carleton
Longitudinal Monitoring of ctDNA to Facilitate Surgical De-Escalation and Disease Surveillance in Older Women with ER+ Breast Cancer on Primary Endocrine Therapy: A Prospective, Pragmatic, Hybrid-Decentralized Trial with Correlative Analyses
Poster #P4-03-29 | Dec. 12 | Presenter: Devora Isseroff, MD
Patient (Pt) reported anxiety levels during ctDNA surveillance in early-stage triple negative (TNBC) and hormone receptor positive (HR+) breast cancer (BC)
Poster #P3-01-22 | Dec. 12 | Presenter: Mrinalini Ramesh, DO
Pilot feasibility study of ctDNA testing in breast cancer and its association with pain, stress and anxiety
Poster #P5-12-19 | Dec. 13 | Presenter: Mridula George, MD
Patient-reported outcomes from the CIPHER study
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241125653673/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 are the key findings from the ZEST clinical trial presented by Natera (NTRA) at SABCS 2023?
The ZEST trial showed that patients treated with niraparib achieved a median disease-free survival of 11.4 months compared to 5.4 months in the placebo group, with 90% of enrolled patients having Triple Negative Breast Cancer.
What percentage of Signatera-positive patients showed targetable genomic alterations in Natera’s clinical genomics study?
44% of Signatera-positive patients (127/287) had at least one targetable genomic alteration, with 34.5% specifically showing PIK3CA mutations.
How many abstracts is Natera (NTRA) presenting at the 2023 San Antonio Breast Cancer Symposium?
Natera is presenting a total of six abstracts at SABCS, including data from the ZEST clinical trial, clinical genomics database experience, and four abstracts on patient-reported outcomes.
What did Natera’s patient-reported outcomes studies reveal about ctDNA testing?
The studies showed that ctDNA testing can provide valuable information for treatment planning while not causing increased anxiety in patients.
