AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in The Journal of Thoracic and Cardiovascular Surgery demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to risk stratify and detect recurrence early in patients with resected stage I-II non-small cell lung cancer (NSCLC).

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，今天宣布了一项发表在《胸心血管外科杂志》上的新研究，证明了Natera个性化和肿瘤信息分子残留病（MRD）检测的能力，Signatera，对切除的I-II期非小细胞肺癌（NSCLC）患者进行风险分层并早期发现复发。

The full study can be found here..

完整的研究可以在这里找到。。

Worldwide, lung cancer is the second most commonly diagnosed cancer. In the U.S., NSCLC accounts for 81% of all lung cancer diagnoses.1 About 25-30% of NSCLC patients are diagnosed with stage I-II disease.2,3 These patients typically undergo curative-intent complete surgical resection and may be treated with adjuvant systemic therapy.

在世界范围内，肺癌是第二常见的癌症。在美国，非小细胞肺癌占所有肺癌诊断的81%[1]。约25-30%的非小细胞肺癌患者被诊断为I-II期疾病[2,3]。这些患者通常接受根治性完全手术切除，并可能接受辅助全身治疗。

However, 30–55% of patients develop disease recurrence within the first five years after surgery, and five-year overall survival ranges from 68-92% for stage I and 53-60% for stage II NSCLC patients respectively.4,5,6.

然而，30-55%的患者在手术后的前五年内发生疾病复发，五年总生存率分别为I期68-92%和II期NSCLC患者53-60%[4,5,6]。

Given the significant risk of recurrence and death in NSCLC, it is critical to accurately risk-stratify patients to identify who may derive benefit from additional treatment after surgery. In addition, there is a need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms at a time when therapy might provide greater clinical benefit..

鉴于非小细胞肺癌复发和死亡的重大风险，准确地对患者进行风险分层以确定谁可能从手术后的额外治疗中受益至关重要。此外，当治疗可能提供更大的临床益处时，需要敏感和特异的生物标志物来支持在疾病相关症状发作之前早期发现复发。。

This study investigated the association of circulating tumor DNA (ctDNA) status with recurrence-free survival (RFS), as well as changes in clinical practice after a positive ctDNA result in patients with resected stage I-II NSCLC. A total of 378 serial plasma samples from 108 NSCLC patients were analyzed after surgical resection, with a median clinical followup of 16 months..

本研究调查了循环肿瘤DNA（ctDNA）状态与无复发生存期（RFS）的关系，以及切除的I-II期NSCLC患者ctDNA阳性后临床实践的变化。手术切除后，共分析了108例NSCLC患者的378份连续血浆样本，中位临床随访时间为16个月。。

Key findings include:

主要调查结果包括：

Patients who were ctDNA-positive within 6 months post-resection and prior to adjuvant treatment were 53-times more likely to recur (p<0.0001) as compared to ctDNA-negative patients.

与ctDNA阴性患者相比，术后6个月内和辅助治疗前ctDNA阳性的患者复发的可能性高53倍（p＜0.0001）。

ctDNA detection demonstrated a median lead time of 5.5 months when compared to confirmation of recurrence by radiographic imaging.

与通过放射成像确认复发相比，ctDNA检测显示中位前置时间为5.5个月。

Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment.

100%的ctDNA阳性患者（早期影像学检查）术后监测策略发生了改变，PET扫描阳性的恶性特征患者接受了早期转诊治疗。

“This study demonstrates that serial monitoring with Signatera can identify patients who are most likely to benefit from adjuvant systemic therapy and/or more intensified imaging,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “With measurable clinical impact in 100% of Signatera MRD-positive cases, this study supports the utility of Signatera in the management of non-metastatic, resected NSCLC.”.

Natera肿瘤学首席医学官Minetta Liu医学博士说：“这项研究表明，使用Signatera进行连续监测可以确定最有可能从辅助全身治疗和/或更强化成像中受益的患者。”。“在100%的Signatera MRD阳性病例中具有可测量的临床影响，这项研究支持Signatera在非转移性切除NSCLC管理中的应用。”。

The study builds on previous Signatera data across early- and late-stage NSCLC. This includes a 2023 publication in Frontiers in Oncology, demonstrating Signatera’s ability to risk stratify and detect progression early in unresectable NSCLC,7 as well as the EMPower Lung-1 trial presented at the 2023 ASCO annual meeting, which showed Signatera’s ability to monitor response to immunotherapy and predict clinical outcomes in advanced NSCLC patients.8 This recent work also builds upon the 2017 TRACERx Nature publication that first reported Signatera’s ability to detect relapse early with high sensitivity and specificity in patients with resected NSCLC.9.

该研究基于早期和晚期NSCLC的先前Signatera数据。这包括2023年在《肿瘤学前沿》上发表的一篇出版物，展示了Signatera在不可切除的非小细胞肺癌早期进行风险分层和检测进展的能力，7以及在2023年ASCO年会上提出的EMPower Lung-1试验，这表明Signatera能够监测晚期非小细胞肺癌患者对免疫治疗的反应并预测临床结果[8]。最近的这项工作还建立在2017年TRACERx Nature出版物的基础上，该出版物首次报道了Signatera能够在切除的非小细胞肺癌患者中以高灵敏度和特异性早期检测复发[9]。

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来检测和量化体内残留的癌症，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 (stage IIb and higher) 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，适用于结直肠癌，乳腺癌（IIb期及以上）和肌肉浸润性膀胱癌患者的医疗保险，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.

纳特拉™ 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提供给患者、提供者和付款人的好处。

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。。

References

参考文献

Cancer.Net. Lung Cancer (Non-Small Cell) - Statistics. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. 2023.

癌症。净额。肺癌（非小细胞）-统计。https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.2023

Cancer of the Lung and Bronchus (Invasive). In: Howlader N, Noone AM, Krapcho M, et al. editors. SEER Cancer Statistics Review, 1975-2014. Bethesda, MD: National Cancer Institute, 2017.

肺癌和支气管癌（侵袭性）。在：Howlader N，Noone AM，Krapcho M等编辑。SEER癌症统计评论，1975-2014。马里兰州贝塞斯达：国家癌症研究所，2017年。

Kocher F, Hilbe W, Seeber A, et al. Longitudinal analysis of 2293 NSCLC patients: A comprehensive study from the TYROL registry. Lung Cancer. 2015;87(2):193-200. doi:10.1016/j.lungcan.2014.12.006

Kocher F，Hilbe W，Seeber A等。2293例非小细胞肺癌患者的纵向分析：TYROL登记处的综合研究。肺癌。2015年；87（2）：193-200。doi:10.1016/j.lungcan.2014.12.006

Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. Transl Lung Cancer Res. 2014;3(4):242-249. doi:10.3978/j.issn.2218-6751.2013.12.05

Uramoto H，Tanaka F.NSCLC患者手术后复发。Transl Lung Cancer Res.2014；3（4）：242-249。doi:10.3978/j.issn.2218-6751.2013.12.05

Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. Annals of Thoracic Surgery. 2014;98(5):1755-1761. doi:10.1016/j.athoracsur.2014.05.070

Lou F，Sima CS，Rusch VW，Jones DR，Huang J.早期与局部晚期非小细胞肺癌复发模式的差异。胸外科年鉴。2014年；98（5）：1755-1761。doi:10.1016/j.athoracsur.2014.05.070

Journal of Thoracic Oncology 2016 1139-51DOI: (10.1016/j.jtho.2015.09.009)

胸部肿瘤学杂志2016 1139-51DOI：（10.1016/j.jtho。2015.09.009）

Lebow et al. ctDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy. Front. Oncol. 2023,13:1253629.

Lebow等人。基于ctDNA检测接受确定性放疗的I-III期非小细胞肺癌患者的分子残留疾病。正面。Oncol公司。2023,13:1253629。

Vokes N, Gandara D, et al. Circulating Tumor DNA (ctDNA) Dynamics and Survival Outcomes in Patients with Advanced NSCLC and High (>50%) PD-L1 Expression, Randomized to Cemiplimab vs Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June 2023.

Vokes N，Gandara D等人。晚期NSCLC和PD-L1高表达（>50%）患者的循环肿瘤DNA（ctDNA）动力学和生存结果，随机分为Cemiplimab组和化疗组。在2023年6月于伊利诺伊州芝加哥举行的ASCO年会上发表。

Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.

Abbosh C，Birkbak NJ，Wilson GA等。系统发育ctDNA分析描述了早期肺癌的演变。自然。2017年；545（7655）：446-451。