Natera to Present New SignateraTM Data in Multiple Abstracts at the San Antonio Breast Cancer Symposium
Natera to Present New SignateraTM Data in Multiple Abstracts at the San Antonio Breast Cancer Symposium
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.
得克薩斯州奧斯汀--(美國商業資訊)--無細胞DNA和基因檢測領域的全球領導者Natera公司(納斯達克股票代碼:NTRA)今天宣佈,將在12月10日至13日在德克薩斯州聖安東尼奧舉行的聖安東尼奧乳腺癌研討會(SABCS)上公佈新的SignateraTM數據。Natera及其合作者將總共提交六份摘要。
"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.
Natera高級醫學董事安吉爾·羅德里格茲萬博士說:「我們很自豪能夠在SABCS分享有關Signatera的新數據,這凸顯了我們致力於提供證據,證明Signatera對乳腺癌患者的臨床用途。」
The full list of abstracts with selected highlights are as follows:
摘要的完整清單和精選亮點如下:
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 臨床試驗
口頭演講 #GS3 -01 | 12 月 13 日 | 主持人:尼古拉斯·特納,醫學博士,FRCP,FMedSci
ZeST的循環腫瘤DNA監測,這是一項針對三陰性乳腺癌患者或HR+ HER2− BRCA突變乳腺癌患者進行明確治療後伴有分子殘留疾病的niraparib或安慰劑的隨機3期雙盲研究
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).
Zest是一項由葛蘭素史克贊助的隨機III期雙盲試驗,該試驗評估了在完成治療意圖治療後呈ctDNA陽性且沒有放射覆發證據的乳腺癌患者的無病存活率。共有2746名患者接受了預篩查。在ctDNA陽性的患者中,有40名患者入組並進行了隨機分組(尼拉帕尼,18例;安慰劑,22例);36名患者(90%)患有三陰性乳腺癌(TNBC),4名患者(10%)患有BRCA突變的HR+疾病。對隨機患者預後的分析顯示,尼拉帕尼組的無病存活率中位數爲11.4個月,而安慰劑組的無病存活率中位數爲5.4個月(危險比爲0.64;95% 置信區間,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
臨床基因組學數據庫經驗
海報聚焦 #PS9 -01 | 12 月 12 日 | 主持人:醫學博士 Marla Lipsyc-Sharf
局部激素受體陽性 (HR+) 乳腺癌的可操作基因組變化及其對臨床結果的影響:綜合全外顯子組測序 (WES) 和腫瘤信息循環腫瘤 DNA (ctDNA) 分析的結果
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).
這項真實世界的分析評估了早期乳腺癌中靶向腫瘤基因組變化與ctDNA檢測和遠距離無復發生存(DRFS)的關係。在這項研究中,44% 的 Signatera 陽性患者(127/287)有至少一種可靶向的基因組變異,包括 34.5% 的 PIK3CA 突變。此外,在2年內出現ctDNA陽性的患者中,與野生型 PIK3CA 患者(HR=16.3)相比,PIK3CA 突變患者的DRFS(HR:36.9)較差。
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.
患者報告的結果
將在SABCS上發表的四份摘要對患者報告的循環腫瘤DNA(ctDNA)檢測結果進行了評估。數據表明,ctDNA測試可以爲治療計劃提供有價值的信息,同時不會增加患者的焦慮感。
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
海報 #P2 -03-21 | 12 月 11 日 | 主持人:尼爾·卡爾頓
縱向監測 ctDNA 以促進接受原發內分泌治療的 ER+ 乳腺癌老年女性的手術緩解和疾病監測:一項具有相關分析的前瞻性、務實性、混合分散型試驗
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)
海報 #P4 -03-29 | 12 月 12 日 | 主持人:醫學博士德沃拉·伊瑟羅夫
患者(Pt)報告了早期三陰性(TNBC)和激素受體陽性(HR+)乳腺癌(BC)的ctDNA監測期間的焦慮水平
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
海報 #P3 -01-22 | 12 月 12 日 | 主持人:DO Mrinalini Ramesh
乳腺癌ctDNA檢測及其與疼痛、壓力和焦慮的關係的試點可行性研究
Poster #P5-12-19 | Dec. 13 | Presenter: Mridula George, MD
Patient-reported outcomes from the CIPHER study
海報 #P5 -12-19 | 12 月 13 日 | 主持人:馬裏杜拉·喬治,醫學博士
患者報告的CIPHER研究結果
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.
關於 Signatera
Signatera是一項個性化、以腫瘤爲依據的分子殘留疾病檢測,適用於先前被診斷患有癌症的患者。Signatera爲每個人量身定製,使用循環腫瘤DNA來檢測和量化遺留在體內的癌症,比標準護理工具更早地識別復發情況,並幫助優化治療決策。該測試可用於臨床和研究用途,由Medicare承保,適用於結直腸癌、乳腺癌、卵巢癌和肌肉浸潤性膀胱癌患者,以及任何實體瘤的免疫療法監測。Signatera已通過多種癌症類型和適應症的臨床驗證,在100多篇同行評審論文中發表了證據。
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 .
關於 Natera
Natera是無細胞DNA和基因檢測領域的全球領導者,致力於腫瘤學、女性健康和器官健康。我們的目標是將個性化基因檢測和診斷作爲護理標準的一部分,以保護健康,爲更早、更有針對性的干預措施提供信息,幫助人們過上更長壽、更健康的生活。Natera的測試得到了250多份經過同行評審的出版物的驗證,這些出版物顯示出很高的準確性。Natera在德克薩斯州奧斯汀和加利福尼亞州聖卡洛斯設有經ISO 13485認證和CAP認證的實驗室,這些實驗室經臨床實驗室改進修正案(CLIA)認證。欲了解更多信息,請訪問。
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 and www.sec.gov.
前瞻性陳述
除本新聞稿中包含的歷史事實陳述外,所有陳述均爲前瞻性陳述,並不代表納泰拉的計劃、估計或預期將得到實現。這些前瞻性陳述代表了納泰拉截至本新聞稿發佈之日的預期,納泰拉不承擔任何更新前瞻性陳述的義務。這些前瞻性陳述受已知和未知的風險和不確定性的影響,這些風險和不確定性可能導致實際結果存在重大差異,包括臨床研究或其他研究的結果是否支持我們產品的使用、此類研究結果的影響、我們對測試可靠性、準確性和性能的期望,或者我們的測試和產品向患者、提供者和付款人帶來的好處。Natera最近提交的10-k和10-Q表格的 「風險因素」 以及納泰拉不時向美國證券交易委員會提交的其他文件中詳細討論了其他風險和不確定性。這些文件可在和www.sec.gov上查閱。
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
投資者關係:邁克·布羅菲,Natera, Inc. 首席財務官,510-826-2350,investor@natera.com
媒體:Natera, Inc. 企業傳播副總裁萊斯利·博格達諾,pr@natera.com
Source: Natera, Inc.
資料來源:Natera, Inc.
譯文內容由第三人軟體翻譯。