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.
得克萨斯州奥斯汀--(美国商业资讯)--无细胞DNA和基因检测领域的全球领导者Natera公司(纳斯达克股票代码:NTRA)今天宣布,将在12月10日至13日在德克萨斯州圣安东尼奥举行的圣安东尼奥乳腺癌研讨会(SABCS)上公布新的SignateraTM数据。Natera及其合作者将总共提交六份摘要。
"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高级医学董事安吉尔·罗德里格兹万博士说:“我们很自豪能够在SABCS分享有关Signatera的新数据,这凸显了我们致力于提供证据,证明Signatera对乳腺癌患者的临床用途。”
The full list of abstracts with selected highlights are as follows:
摘要的完整清单和精选亮点如下:
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 临床试验
口头演讲 #GS3 -01 | 12 月 13 日 | 主持人:尼古拉斯·特纳,医学博士,FRCP,FMedSci
ZeST的循环肿瘤DNA监测,这是一项针对三阴性乳腺癌患者或HR+ HER2− BRCA突变乳腺癌患者进行明确治疗后伴有分子残留疾病的niraparib或安慰剂的随机3期双盲研究
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是一项由葛兰素史克赞助的随机III期双盲试验,该试验评估了在完成治疗意图治疗后呈ctDNA阳性且没有放射复发证据的乳腺癌患者的无病存活率。共有2746名患者接受了预筛查。在ctDNA阳性的患者中,有40名患者入组并进行了随机分组(尼拉帕尼,18例;安慰剂,22例);36名患者(90%)患有三阴性乳腺癌(TNBC),4名患者(10%)患有BRCA突变的HR+疾病。对随机患者预后的分析显示,尼拉帕尼组的无病存活率中位数为11.4个月,而安慰剂组的无病存活率中位数为5.4个月(危险比为0.64;95% 置信区间,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
临床基因组学数据库经验
海报聚焦 #PS9 -01 | 12 月 12 日 | 主持人:医学博士 Marla Lipsyc-Sharf
局部激素受体阳性 (HR+) 乳腺癌的可操作基因组变化及其对临床结果的影响:综合全外显子组测序 (WES) 和肿瘤信息循环肿瘤 DNA (ctDNA) 分析的结果
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).
这项真实世界的分析评估了早期乳腺癌中靶向肿瘤基因组变化与ctDNA检测和远距离无复发生存(DRFS)的关系。在这项研究中,44% 的 Signatera 阳性患者(127/287)有至少一种可靶向的基因组变异,包括 34.5% 的 PIK3CA 突变。此外,在2年内出现ctDNA阳性的患者中,与野生型 PIK3CA 患者(HR=16.3)相比,PIK3CA 突变患者的DRFS(HR:36.9)较差。
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.
患者报告的结果
将在SABCS上发表的四份摘要对患者报告的循环肿瘤DNA(ctDNA)检测结果进行了评估。数据表明,ctDNA测试可以为治疗计划提供有价值的信息,同时不会增加患者的焦虑感。
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
海报 #P2 -03-21 | 12 月 11 日 | 主持人:尼尔·卡尔顿
纵向监测 ctDNA 以促进接受原发内分泌治疗的 ER+ 乳腺癌老年女性的手术缓解和疾病监测:一项具有相关分析的前瞻性、务实性、混合分散型试验
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)
海报 #P4 -03-29 | 12 月 12 日 | 主持人:医学博士德沃拉·伊瑟罗夫
患者(Pt)报告了早期三阴性(TNBC)和激素受体阳性(HR+)乳腺癌(BC)的ctDNA监测期间的焦虑水平
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
海报 #P3 -01-22 | 12 月 12 日 | 主持人:DO Mrinalini Ramesh
乳腺癌ctDNA检测及其与疼痛、压力和焦虑的关系的试点可行性研究
Poster #P5-12-19 | Dec. 13 | Presenter: Mridula George, MD
Patient-reported outcomes from the CIPHER study
海报 #P5 -12-19 | 12 月 13 日 | 主持人:马里杜拉·乔治,医学博士
患者报告的CIPHER研究结果
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.
关于 Signatera
Signatera是一项个性化、以肿瘤为依据的分子残留疾病检测,适用于先前被诊断患有癌症的患者。Signatera为每个人量身定制,使用循环肿瘤DNA来检测和量化遗留在体内的癌症,比标准护理工具更早地识别复发情况,并帮助优化治疗决策。该测试可用于临床和研究用途,由Medicare承保,适用于结直肠癌、乳腺癌、卵巢癌和肌肉浸润性膀胱癌患者,以及任何实体瘤的免疫疗法监测。Signatera已通过多种癌症类型和适应症的临床验证,在100多篇同行评审论文中发表了证据。
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 .
关于 Natera
Natera是无细胞DNA和基因检测领域的全球领导者,致力于肿瘤学、女性健康和器官健康。我们的目标是将个性化基因检测和诊断作为护理标准的一部分,以保护健康,为更早、更有针对性的干预措施提供信息,帮助人们过上更长寿、更健康的生活。Natera的测试得到了250多份经过同行评审的出版物的验证,这些出版物显示出很高的准确性。Natera在德克萨斯州奥斯汀和加利福尼亚州圣卡洛斯设有经ISO 13485认证和CAP认证的实验室,这些实验室经临床实验室改进修正案(CLIA)认证。欲了解更多信息,请访问。
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.
前瞻性陈述
除本新闻稿中包含的历史事实陈述外,所有陈述均为前瞻性陈述,并不代表纳泰拉的计划、估计或预期将得到实现。这些前瞻性陈述代表了纳泰拉截至本新闻稿发布之日的预期,纳泰拉不承担任何更新前瞻性陈述的义务。这些前瞻性陈述受已知和未知的风险和不确定性的影响,这些风险和不确定性可能导致实际结果存在重大差异,包括临床研究或其他研究的结果是否支持我们产品的使用、此类研究结果的影响、我们对测试可靠性、准确性和性能的期望,或者我们的测试和产品向患者、提供者和付款人带来的好处。Natera最近提交的10-k和10-Q表格的 “风险因素” 以及纳泰拉不时向美国证券交易委员会提交的其他文件中详细讨论了其他风险和不确定性。这些文件可在和www.sec.gov上查阅。
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
投资者关系:迈克·布罗菲,Natera, Inc. 首席财务官,510-826-2350,investor@natera.com
媒体:Natera, Inc. 企业传播副总裁莱斯利·博格达诺,pr@natera.com
Source: Natera, Inc.
资料来源:Natera, Inc.