The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with TTFields therapy and supportive care compared to 11.3 months for patients treated with supportive care alone

METIS试验显示，接受TTFields治疗和支持治疗的患者颅内进展的中位时间为21.9个月，而单独接受支持治疗的患者为11.3个月

Patients treated with TTFields therapy experienced prolonged quality of life deterioration-free survival and TTFields therapy was well-tolerated

接受TTFields治疗的患者生活质量延长，无恶化生存期，TTFields治疗耐受性良好

Data from the METIS trial to be presented today during the 2024 ASCO Annual Meeting

METIS试验的数据将于今天在2024年ASCO年会上提交

ROOT, Switzerland–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) today announced the presentation of clinical data from the phase 3 METIS trial, which investigated the use of Tumor Treating Fields (TTFields) therapy in the treatment of brain metastases from non-small cell lung cancer (NSCLC). These data will be presented at the ongoing 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago..

瑞士ROOT——（商业新闻短讯）——Novocure（纳斯达克：NVCR）今天宣布了第三阶段METIS试验的临床数据，该试验研究了肿瘤治疗场（TTFields）疗法在治疗非小细胞肺癌（NSCLC）脑转移中的应用。这些数据将在正在芝加哥举行的2024年美国临床肿瘤学会（ASCO）年会上公布。。

The METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, who were randomized following stereotactic radiosurgery (SRS) to receive either TTFields therapy and best supportive care (BSC) (n=149) or BSC alone (n=149). METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression.

METIS试验招募了298名患有1-10例NSCLC脑转移的成年患者，他们在立体定向放射外科手术（SRS）后随机接受TTFields治疗和最佳支持治疗（BSC）（n=149）或单独接受BSC（n=149）。METIS达到了其主要终点，证明了颅内进展时间的统计学显着改善。

Patients treated with TTFields therapy and BSC exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with BSC alone (hazard ratio=0.67; P=0.016). Median TTFields therapy duration was 16 weeks and median usage was 67%. Baseline patient demographics and characteristics were well balanced between arms..

接受TTFields治疗和BSC治疗的患者颅内进展的中位时间为21.9个月，而单独使用BSC治疗的患者为11.3个月（风险比=0.67；P=0.016）。中位TTFields治疗持续时间为16周，中位使用率为67%。基线患者人口统计学和特征在手臂之间平衡良好。。

Patients treated with TTFields therapy demonstrated improved quality of life deterioration-free survival, with median time to quality of life deterioration-free survival not reached in the TTFields therapy cohort compared to 7.7 months in control arm (P=0.038). A positive trend was observed in patients treated with TTFields therapy in the majority of scales and items assessed by the EORTC QLQ C30 and BN20 patient questionnaire.

接受TTFields治疗的患者表现出改善的生活质量无恶化生存期，与对照组的7.7个月相比，TTFields治疗队列中未达到生活质量无恶化生存期的中位时间（P=0.038）。在EORTC QLQ C30和BN20患者问卷评估的大多数量表和项目中，接受TTFields治疗的患者出现了积极的趋势。

There was no evidence of worsening cognitive functioning in the TTFields therapy arm compared to the control arm. Consistent with prior clinical trials, TTFields therapy was well-tolerated with no additive systemic toxicity..

与对照组相比，没有证据表明TTFields治疗组的认知功能恶化。与之前的临床试验一致，TTFields疗法耐受性良好，没有附加的全身毒性。。

Preliminary analyses of key secondary endpoints did not demonstrate statistical significance. Median overall survival for patients randomized to receive TTFields therapy and BSC was 11.3 months compared to 10.6 months in patients treated with BSC alone. Full analysis of secondary endpoints is ongoing..

关键次要终点的初步分析没有显示统计学意义。随机接受TTFields治疗和BSC治疗的患者的中位总生存期为11.3个月，而单独接受BSC治疗的患者为10.6个月。正在对次要终点进行全面分析。。

“One of the key challenges in combatting the spread of brain metastases is maintaining patients’ quality of life and cognitive function,” said lead investigator Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. “The ability of TTFields therapy to prolong the time to intracranial progression without negatively impacting either quality of life or cognitive function has the potential to change the way brain metastases from non-small cell lung cancer are treated.”.

首席研究员、放射肿瘤学负责人、迈阿密癌症研究所副所长、佛罗里达州南浸礼会健康会的一部分Minesh Mehta医学博士说：“对抗脑转移瘤扩散的关键挑战之一是维持患者的生活质量和认知功能。TTFields疗法能够延长颅内进展时间，而不会对生活质量或认知功能产生负面影响，有可能改变非小细胞肺癌脑转移的治疗方式。”。

“Despite the high incidence level of brain metastases from NSCLC, the treatment options available for patients are very limited,” said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. “The observations from the METIS trial are an important first step in potentially adding a new treatment option for these patients and we are eager to pursue the necessary steps to ensure TTFields therapy is available to those in need.”.

Novocure首席医疗官Nicolas Leupin医学博士说：“尽管非小细胞肺癌脑转移的发病率很高，但患者可用的治疗选择非常有限。”。“METIS试验的观察结果是为这些患者增加新治疗选择的重要第一步，我们渴望采取必要步骤，确保TTFields治疗可供需要的患者使用。”。

These data will be featured by Dr. Mehta in an oral presentation (abstract #2008) at 10:24 a.m. CDT on Monday, June 3, 2024 during ASCO’s Central Nervous System Tumors session. Novocure intends to publish these findings in a peer-reviewed scientific journal and submit these data to regulatory authorities..

这些数据将由Mehta博士在2024年6月3日星期一的ASCO中枢神经系统肿瘤会议期间于CDT上午10:24进行口头介绍（摘要#2008）。Novocure打算在同行评审的科学期刊上发表这些发现，并将这些数据提交给监管机构。。

About METIS

关于METIS

METIS [NCT02831959] is a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS.

METIS[NCT02831959]是一项立体定向放射外科手术的3期临床试验，有或没有TTFields治疗，用于1-10例NSCLC脑转移患者。298名成年患者参加了该试验，并随机接受TTFields治疗和支持治疗或SRS后单独支持治疗。

Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician.

支持治疗包括但不限于类固醇，抗癫痫药，抗凝剂，疼痛控制或恶心控制药物的治疗。该研究的两个部分的患者都有资格根据其主治医师的判断接受NSCLC的全身治疗。

Patients with known tumor mutations for which targeted agents are available were excluded from the trial..

具有已知肿瘤突变且可获得靶向药物的患者被排除在试验之外。。

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function.

METIS试验的主要终点是首次颅内进展的时间，从首次SRS治疗日期到颅内进展或神经系统死亡（根据RANO-BM标准），以先发生者为准。根据累积事件函数计算颅内进展时间。

Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful.

患者扫描由不知情的独立放射学审查委员会进行评估。次要终点包括但不限于远处进展时间，神经认知衰竭时间，总生存期，第二次颅内进展时间，生活质量和不良事件。如果成功，计划将关键的次要终点（神经认知衰竭的时间，总生存期和放射学反应率）用于标记索赔。

Full analysis of secondary endpoints is ongoing. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression..

正在对次要终点进行全面分析。根据脑转移的数量（1-4或5-10个转移），先前的全身治疗和肿瘤组织学对患者进行分层。在确认第二次颅内进展后，允许患者交叉到实验性TTFields治疗组。。

About Tumor Treating Fields Therapy

关于肿瘤治疗领域的治疗

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells.

肿瘤治疗场（TTFields）是通过多种机制施加物理力杀死癌细胞的电场。TTFields不会显着影响健康细胞，因为它们具有与癌细胞不同的特性（包括分裂速率，形态和电特性）。

The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models.

TTFields疗法的多种不同机制共同作用以选择性靶向和杀死癌细胞。由于其多机制作用，TTFields治疗可以在批准的适应症中添加到癌症治疗模式中，并且在临床前模型中与化疗，放疗，免疫检查点抑制或靶向治疗一起使用时，可以在实体瘤类型中显示出增强的效果。

TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com..

TTFields疗法提供了临床多功能性，有可能帮助解决一系列实体瘤的治疗挑战。要了解更多有关肿瘤治疗场疗法及其对癌细胞的多方面影响的信息，请访问tumortreatingfields.com。。

About Novocure

关于Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma.

Novocure是一家全球性肿瘤公司，致力于通过其创新疗法，肿瘤治疗领域的开发和商业化，延长一些最具侵袭性的癌症的生存期。Novocure的商业化产品在某些国家被批准用于治疗成人胶质母细胞瘤和恶性胸膜间皮瘤患者。

Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer..

Novocure正在进行或完成临床研究，调查脑转移瘤，胃癌，胶质母细胞瘤，肝癌，非小细胞肺癌，胰腺癌和卵巢癌的肿瘤治疗领域。。

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter..

Novocure总部位于瑞士Root，全球足迹不断扩大，在朴茨茅斯、新罕布什尔州和东京设有区域运营中心，在以色列海法设有研究中心。有关该公司的更多信息，请访问Novocure.com，并在LinkedIn和Twitter上关注@Novocure。。

Forward-Looking Statements

前瞻性声明

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts.

除了历史事实或现状声明外，本新闻稿可能还包含前瞻性声明。前瞻性声明提供了Novocure目前对未来事件的预期或预测。这些可能包括关于其研究计划的预期科学进展、临床研究进展、潜在产品的开发、临床结果的解释、监管批准的前景、制造发展和能力、其产品的市场前景、覆盖范围、第三方付款人的收款以及其他关于非历史事实的陈述。

You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S.

您可以通过在声明中使用诸如“预期”、“估计”、“预期”、“项目”、“打算”、“计划”、“相信”或其他类似含义的词语和术语来识别其中一些前瞻性声明。由于一般的财务、经济、环境、监管和政治条件以及Novocure面临的其他更具体的风险和不确定性，Novocure的业绩和财务结果可能与这些前瞻性报表中反映的业绩和财务结果存在重大差异，如2024年2月22日提交的10-K表年度报告以及随后提交给美国。

Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law.

证券交易委员会。鉴于这些风险和不确定性，任何或所有这些前瞻性陈述可能被证明是不正确的。因此，您不应依赖任何此类因素或前瞻性陈述。此外，Novocure不打算公开更新任何前瞻性声明，除非法律要求。

Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion..

本文件中的任何前瞻性声明仅在本文件日期起生效。1995年的《私人证券诉讼改革法案》允许进行这种讨论。。

INVESTORS AND MEDIA:

投资者和媒体：

Ingrid Goldberg

英格丽·戈德堡

investorinfo@novocure.com

investorinfo@novocure.com

media@novocure.com

media@novocure.com

Source: Novocure

来源：Novocure