AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced an analysis from the IMvigor011 study that was presented at the European Association of Urology (EAU) Congress 2024 in Paris, France. The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test..

德克萨斯州奥斯汀——（商业新闻短讯）——Natera，Inc.（纳斯达克：NTRA），无细胞DNA检测的全球领导者，今天宣布了IMvigor011研究的分析，该研究已在2024年法国巴黎欧洲泌尿外科协会（EAU）大会上发表。该分析评估了肌肉浸润性膀胱癌（MIBC）患者的预后，这些患者通过Signatera™检测连续阴性，这是Natera的个性化和肿瘤信息分子残留病（MRD）检测。。

Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy. Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs.

IMvigor011由罗氏集团（Roche group）成员基因泰克（Genentech）赞助，是一项全球性、双盲、随机的III期临床试验，在该试验中，高危MIBC患者在膀胱切除术后长达12个月内接受Signatera连续检测。在12个月的监测窗口内的任何时候检测Signatera MRD阳性的患者被随机分配到抗PDL1 atezolizumab（Tecentriq®）vs。

placebo. Patients who remain Signatera-negative at completion of the testing window are not randomized but continue to undergo radiographic imaging thereafter..

安慰剂。在测试窗口完成时仍保持Signatera阴性的患者不是随机的，而是在此后继续进行放射成像。。

The analysis presented at the EAU Congress evaluated clinical outcomes in 171 high-risk MIBC patients who entered screening for IMvigor011 and remained MRD-negative during the surveillance window. Key takeaways from the presentation include:

EAU大会上提出的分析评估了171名高危MIBC患者的临床结果，这些患者进入了IMvigor011筛查，并在监测窗口期间保持MRD阴性。演讲的要点包括：

Overall survival (OS) rates of 100% at 12 months and 98% at 18 months, in patients who remained serially MRD-negative.

在连续MRD阴性的患者中，总生存率（OS）在12个月时为100%，在18个月时为98%。

Disease-free survival (DFS) rates of 92% at 12 months and 88% at 18 months, in patients who remained serially MRD-negative.

在连续MRD阴性的患者中，无病生存率（DFS）在12个月时为92%，在18个月时为88%。

Concludes that patients who remain MRD-negative on serial testing may be spared from adjuvant treatment.

结论是，在连续检测中MRD阴性的患者可以免于辅助治疗。

“IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle-invasive bladder cancer,” said John Simmons, vice president, BioPharma at Natera. “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.

Natera生物制药副总裁约翰·西蒙斯（JohnSimmons）表示：“IMvigor011是一项重要的随机研究，旨在解决每年35000多名被诊断患有肌肉浸润性膀胱癌的患者的严重未满足需求。”。“我们相信这项试验的结果将进一步证明Signatera如何帮助个性化治疗决策并改善膀胱癌患者的预后。

Together with Professor Powles and our collaborators at Genentech, we look forward to the full trial read-out which could serve as the basis of Natera’s first FDA companion diagnostic submission for Signatera.”.

与鲍尔斯教授和我们在基因泰克的合作者一起，我们期待着全面的试验宣读，这可以作为Natera首次向Signatera提交FDA伴随诊断的基础。”。

This presentation follows a study published in Nature based on the phase III randomized IMvigor010 trial, which showed that patients who tested Signatera MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy with atezolizumab, while Signatera-negative patients derived no significant benefit from adjuvant therapy..

本报告是在《自然》杂志发表的一项基于III期随机IMvigor010试验的研究之后发表的，该研究表明，根治性膀胱切除术后检测到Signatera MRD阳性的患者从atezolizumab的辅助免疫治疗中获得了显着的益处，而Signatera阴性的患者则没有从辅助治疗中获得显着的益处。。

As previously announced in October 2023, Natera submitted the first module of its premarket approval application to the U.S. Food and Drug Administration (FDA) for Signatera as a companion diagnostic (CDx) assay for patients with MIBC.

正如之前在2023年10月宣布的那样，Natera向美国食品和药物管理局（FDA）提交了上市前批准申请的第一个模块，用于Signatera作为MIBC患者的伴随诊断（CDx）检测。

Note: Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

注：Tecentriq® （atezolizumab）是罗氏集团成员基因泰克的注册商标。

About Signatera

关于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.

Signatera是一种针对先前诊断为癌症的患者的个性化，肿瘤信息，分子残留疾病测试。Signatera为每个人定制，使用循环肿瘤DNA来检测和量化留在体内的癌症，比标准护理工具更早地识别复发，并帮助优化治疗决策。

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 50 peer-reviewed papers..

该测试可用于临床和研究用途，并由Medicare覆盖，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治疗监测。Signatera已在多种癌症类型和适应症中得到临床验证，并在50多篇同行评审论文中发表了证据。。

About Natera

关于Natera

Natera™ is a global leader in cell-free DNA 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™是无细胞DNA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。我们的目标是使个性化的基因检测和诊断成为保护健康的护理标准的一部分，并为更早，更有针对性的干预措施提供信息，以帮助人们获得更长，更健康的生活。

Natera’s tests are validated by more than 180 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..

Natera的测试得到了180多份同行评审出版物的验证，这些出版物具有很高的准确性。Natera在德克萨斯州奥斯汀和加利福尼亚州圣卡洛斯运营着根据临床实验室改进修正案（CLIA）认证的ISO 13485认证和CAP认证实验室。有关更多信息，请访问www.natera.com。。

Forward-Looking Statements

前瞻性声明

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.

除本新闻稿中包含的历史事实声明外，所有声明均为前瞻性声明，并不表示Natera的计划、估计或预期将得以实现。截至本新闻稿发布之日，这些前瞻性声明代表了Natera的期望，Natera不承担更新前瞻性声明的任何义务。

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.

这些前瞻性陈述受到已知和未知风险和不确定性的影响，这些风险和不确定性可能会导致实际结果产生重大差异，包括临床或其他研究的结果是否会支持我们产品的使用，此类研究结果的影响，我们对测试的可靠性，准确性和性能的期望，或我们的测试和产品对患者，提供者和付款人的益处。

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..

Natera最近在10-K和10-Q表格上提交的文件以及Natera不时向SEC提交的其他文件中的“风险因素”更详细地讨论了其他风险和不确定性。这些文件可在www.natera.com/investors和www.sec.gov上查阅。。