适用于肿瘤的可穿戴医疗器械获得FDA批准用于治疗癌症-动脉网

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News 等信源发布 2024-10-17 02:41

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Lung cancer can be treated with small molecules formulated as pills as well as biological medications that are injected or infused, both as standalone treatments or as part of drug combinations. A wearable technology is the latest addition to the treatment mix. The FDA has approved a Novocure medical device that uses fields of electricity to kill cancer cells..

肺癌可以用配制成药丸的小分子以及注射或输注的生物药物治疗，既可以作为独立治疗，也可以作为药物组合的一部分。可穿戴技术是治疗组合的最新添加。。。

The regulatory decision announced after Tuesday’s market close covers the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after receiving platinum-based chemotherapy. Root, Switzerland-based Novocure will market the Class 3 medical device under the name Optune Lua..

周二收盘后宣布的监管决定涵盖了成人转移性非小细胞肺癌（NSCLC）的治疗，这些患者的疾病在接受铂类化疗时或之后有所进展。总部位于瑞士Root的Novocure将以Optune Lua的名义销售3类医疗器械。。

Optune Lua produces alternating electrical fields that Novocure calls “Tumor Treating Fields,” or TTFields. Electrical signals from the portable device are delivered by wearable arrays placed directly on the skin. The company says these fields exert physical forces on the electrically charged components of dividing cancer cells, killing them.

。来自便携式设备的电信号通过直接放置在皮肤上的可穿戴阵列传递。该公司表示，这些电场对分裂癌细胞的带电成分施加物理力，杀死它们。

Healthy cells have different properties that are unaffected by TTFields, according to the company. The device is intended to be worn about 18 hours a day..

该公司表示，健康细胞具有不受TTFields影响的不同特性。该设备预计每天佩戴约18小时。。

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Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat.

卫生系统在门户网站上花费了数十亿美元，而对语音频道现代化的投资（这是医疗保健消费者的主要偏好）却处于次要地位。

By Stephanie Baum

作者：StephanieBaum

FDA approval of Optune Lua in NSCLC covers use of the device alongside either a type of immunotherapy called a checkpoint inhibitor or the chemotherapy docetaxel, which is how it was tested in clinical trials. Phase 3 results showed this treatment combination met the main goal of achieving a statistically significant and clinically meaningful 3.3 month extension in median overall survival compared to cohorts that received either a checkpoint inhibitor or docetaxel.

FDA批准Optune Lua用于非小细胞肺癌，包括将该装置与一种称为检查点抑制剂的免疫疗法或化疗多西紫杉醇一起使用，这是它在临床试验中的测试方式。第三阶段的结果显示，与接受检查点抑制剂或多西紫杉醇的队列相比，这种治疗组合达到了中位总生存期延长3.3个月的统计学显着性和临床意义的主要目标。

Preliminary results from this study were reported last year..

去年报道了这项研究的初步结果。。

Looking at the specific cohorts, the Optune Lua and checkpoint inhibitor arm achieved median overall survival of 8 months more compared to treatment with a checkpoint inhibitor alone. The Optune Luna and docetaxel arm showed a median overall survival of 2 months longer than treatment with docetaxel alone, which is short of being statistically significant.

观察特定队列，与单独使用检查点抑制剂治疗相比，Optune Lua和检查点抑制剂组的中位总生存期多了8个月。Optune Luna和多西紫杉醇组的中位总生存期比单独使用多西紫杉醇治疗长2个月，这在统计学上并不显着。

Device-related adverse events, mostly skin-related problems under the electrodes, occurred in 63.1% of patients. These events were classified as mostly low grade and only 4% of study participants experienced a severe enough reaction to require a break from treatment..

63.1%的患者发生了与设备相关的不良事件，主要是电极下的皮肤相关问题。这些事件大多被归类为低级别，只有4%的研究参与者经历了足够严重的反应，需要停止治疗。。

In Novocure’s announcement of the approval, Dr. Ticiana Leal, the primary investigator in the LUNAR Phase 3 study, said NSCLC is an aggressive disease that will progress in most patients. At that point, there are limited treatment options in the second-line setting and beyond.

在Novocure宣布批准的过程中，LUNAR 3期研究的主要研究者Ticiana Leal博士表示，NSCLC是一种侵袭性疾病，大多数患者都会进展。在这一点上，二线治疗和其他治疗选择有限。

“The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than eight years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease,” said Leal, who is an associate professor and director of the thoracic oncology program at the Winship Cancer Institute of the Emory University School of Medicine..

埃默里大学医学院Winship癌症研究所副教授兼胸肿瘤学项目主任Leal说：“我们在LUNAR研究中观察到的Optune Lua的总体生存结果标志着这一患者群体八年多来的首次实质性改善，再加上Optune Lua缺乏全身毒性，这对许多需要更好治疗这种晚期疾病的患者及其医生来说是一个引人注目的发展。”。。

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基于价值的护理和医疗技术创新的承诺

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mHUB MedTech加速器的执行董事莫妮卡·瓦贾尼（MonicaVajani）讨论了mHUB如何帮助创新者将医疗保健转变为基于价值的护理。

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Novocure’s TTFields first reached patients as a treatment for a rare type of brain cancer. In 2011, the FDA approved a device from the company developed to treat the recurrence of glioblastoma multiforme after treatment with chemotherapy. This device is now marketed as Optune Gio. In 2019, an earlier iteration of Optune Lua was approved under a humanitarian device exemption permitting the technology’s use as a treatment for malignant pleural mesothelioma, a cancer affecting the lining of the lungs.

Novocure的TTFields首次用于治疗一种罕见的脑癌。2011年，FDA批准了该公司开发的一种设备，用于治疗化疗后多形性胶质母细胞瘤的复发。该设备现在作为Optune Gio销售。2019年，Optune Lua的早期迭代在人道主义设备豁免下获得批准，允许该技术用于治疗恶性胸膜间皮瘤，这是一种影响肺部衬里的癌症。

This rare cancer is associated with asbestos exposure. Approval in this indication covers cases that cannot be treated surgically..

这种罕见的癌症与石棉暴露有关。本适应症的批准包括无法通过手术治疗的病例。。

Besides the FDA approvals in glioblastoma and mesothelioma, Novocure’s products have marketing authorizations for these indications in Europe, Canada, and Japan and certain other countries. Zai Lab holds rights to commercialize Novocure’s technologies in China, Hong Kong, Macau, and Taiwan.

除了FDA对胶质母细胞瘤和间皮瘤的批准外，Novocure的产品在欧洲，加拿大，日本和某些其他国家也有这些适应症的销售授权。Zai Lab拥有在中国、香港、澳门和台湾将Novocure技术商业化的权利。

In 2023, Novocure reported $509.3 million in revenue, down 5.3% from the previous year. Most of the revenue comes from sales of Optune Gio in the U.S., Germany, and Japan, the company said in its annual report. FDA approval in advanced NSCLC gives Novocure the opportunity to grow revenue by addressing a much more prevalent cancer.

2023年，Novocure报告收入为5.093亿美元，比上年下降5.3%。该公司在年报中表示，大部分收入来自Optune Gio在美国、德国和日本的销售。FDA对晚期非小细胞肺癌的批准使Novocure有机会通过解决更普遍的癌症来增加收入。

In a note sent to investors, Leerink Partners analyst Jonathan Chang wrote that while questions remain about the position of TTFields within the NSCLC treatment landscape, the firm believes the opportunity in this indication could still drive meaningful revenue for Novocure..

Leerink Partners分析师乔纳森·张（JonathanChang）在发给投资者的一份报告中写道，虽然TTFields在非小细胞肺癌治疗领域的地位仍存在疑问，但该公司认为，这一迹象中的机会仍可能为Novocure带来有意义的收入。。

Growth opportunities could also come from expanding the approved uses of the technology. This past spring, Novocure reported positive data from a Phase 3 test of TTFields in patients whose NSCLC metastasized to the brain. Another Phase 3 test is evaluating the device together with chemotherapy as a treatment for pancreatic cancer; preliminary data are expected by the end of this year.

。今年春天，Novocure报告了NSCLC转移到大脑的患者的TTFields 3期测试的阳性数据。另一项3期测试是评估该装置与化疗一起作为胰腺癌的治疗方法；初步数据预计将于今年年底公布。

A Phase 2 trial evaluating TTFields along with chemotherapy and the Roche immunotherapy Tecentriq is currently enrolling pancreatic cancer patients. This study is proceeding under a clinical trial collaboration with Roche. Separately, a fully enrolled Phase 3 clinical trial is evaluating TTFields alongside radiation and chemotherapy as a treatment for glioblastoma.

一项评估TTFields以及化疗和罗氏免疫疗法Tecentriq的2期临床试验目前正在招募胰腺癌患者。这项研究正在与罗氏公司合作进行临床试验。另外，一项完全登记的3期临床试验正在评估TTFields以及放疗和化疗作为胶质母细胞瘤的治疗方法。

Preliminary data from this study are expected in 2026..

这项研究的初步数据预计将于2026年提供。。

“We acknowledge that there is clinical and regulatory risk for each of these opportunities, though also note that TTFields has a positive track record of successful trials and approvals and that positive data in any of these indications could meaningfully expand the opportunity for TTFields,” Chang said..

Chang说：“我们承认，这些机会中的每一个都存在临床和监管风险，但也注意到TTFields在成功的试验和批准方面有着积极的记录，任何这些适应症的积极数据都可以有意义地扩大TTFields的机会。”。。

Photo by Novocure

图片来源：Novocure

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