ROOT, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today announced the results of the METIS phase 3 clinical trial in brain metastases from non-small cell lung cancer (NSCLC) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from May 31 to June 4..

瑞士ROOT——（商业新闻短讯）——Novocure（纳斯达克：NVCR）今天宣布，METIS非小细胞肺癌（NSCLC）脑转移3期临床试验的结果将于5月31日至6月4日在芝加哥举行的2024年美国临床肿瘤学会（ASCO）年会上公布。。

METIS was a randomized phase 3 clinical trial of stereotactic radiosurgery with or without Tumor Treating Fields (TTFields) therapy for patients with 1-10 brain metastases from NSCLC. In March, Novocure announced METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone..

METIS是一项针对1-10例NSCLC脑转移患者的立体定向放射外科治疗的随机3期临床试验，有或没有肿瘤治疗场（TTFields）治疗。3月，Novocure宣布METIS达到了其主要终点，表明与单独的支持治疗相比，接受肿瘤治疗领域（TTFields）治疗和支持治疗的成年患者的颅内进展时间有统计学上的显着改善。。

“We are honored to present the results of the METIS clinical trial as a late-breaking abstract this year at ASCO, the largest global oncology conference,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Patients with brain metastases from non-small cell lung cancer need more treatment options.

Novocure首席执行官阿萨夫·丹泽格（AsafDanziger）表示：“我们很荣幸在今年最大的全球肿瘤学会议ASCO上介绍METIS临床试验的结果，作为最新的摘要。”。“非小细胞肺癌脑转移患者需要更多的治疗选择。

The METIS trial demonstrated that TTFields Therapy delayed intracranial progression while preserving neurological function, which is critical for these underserved patients. We look forward to robust discussion around the positive results of the METIS clinical trial, as well as other TTFields therapy program updates at ASCO 2024.”.

METIS试验表明，TTFields治疗延迟了颅内进展，同时保留了神经功能，这对于这些服务不足的患者至关重要。我们期待着围绕METIS临床试验的积极结果以及ASCO 2024年的其他TTFields治疗计划更新进行强有力的讨论。”。

The METIS data will be presented on June 3 as a late-breaking abstract during ASCO’s Central Nervous System Tumors session from 8 a.m. to 10 a.m. CDT. Lead author Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida, will give the presentation..

METIS的数据将于6月3日作为最新摘要在CDT上午8点至10点的ASCO中枢神经系统肿瘤会议上发布。首席作者、放射肿瘤学主任、迈阿密癌症研究所副所长、医学博士米内斯·梅塔（MineshMehta）将发表演讲。。

The oral presentation of the METIS clinical trial data is one of four abstracts on TTFields therapy to be included at the 2024 ASCO Annual Meeting.

METIS临床试验数据的口头介绍是2024年ASCO年会上关于TTFields治疗的四篇摘要之一。

Abstract titles from Novocure-sponsored and partner programs include:

Novocure赞助和合作伙伴计划的摘要标题包括：

Results from METIS (EF-25), an International, Multicenter Phase III Randomized Study Evaluating the Efficacy and Safety of Tumor Treating Fields (TTFields) Therapy in NSCLC Patients with Brain Metastases. Abstract 2008. 10:24 a.m. CDT on June 3.

METIS（EF-25）的结果是一项国际多中心III期随机研究，评估了肿瘤治疗领域（TTFields）治疗NSCLC脑转移患者的疗效和安全性。摘要2008。10： 美国中部时间6月3日上午24点。

Tumor Treating Fields (TTFields) therapy in patients with glioblastoma: Long-term survival results from TTFields in Germany in routine clinical care (TIGER) study. Abstract 2036. 9 a.m. CDT on June 1.

胶质母细胞瘤患者的肿瘤治疗领域（TTFields）治疗：德国TTFields在常规临床护理（TIGER）研究中的长期生存结果。摘要2036。美国中部时间6月1日上午9点。

LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant with Pembrolizumab and Platinum Based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer. Abstract TPS8665. 1:30 p.m. CDT on June 3.

LUNAR-2：肿瘤治疗领域（TTFields，150 kHz）与Pembrolizumab和铂类化疗联合治疗转移性非小细胞肺癌的关键性，随机，开放标签研究。摘要TPS8665。1： 美国中部时间6月3日下午30点。

Deep Learning Convolutional Neural Networks Reliably Monitor and Accurately Identifies Predictors of Response to Novo-TTFields. Publication Only.

深度学习卷积神经网络可靠地监测并准确识别对新TTFields响应的预测因子。仅限发布。

ABOUT METIS

关于METIS

METIS [NCT02831959] was 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。

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..

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。。

The METIS clinical trial data are expected to serve as the basis for future regulatory discussions.

预计METIS临床试验数据将作为未来监管讨论的基础。

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

关于新固化

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.

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。