ROOT, Switzerland–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma..

瑞士罗特-（商业新闻）-Novocure（纳斯达克：NVCR）今天宣布，关键的3期PANOVA-3试验达到了其主要终点，表明中位总生存期（mOS）与对照组相比有统计学意义上的显着改善。PANOVA-3评估了肿瘤治疗场（TTFields）治疗联合吉西他滨和纳布紫杉醇作为不可切除的局部晚期胰腺癌的一线治疗。。

“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial.

“作为一名研究人员和临床医生，我经历了开发胰腺癌治疗方法的挑战。令人兴奋的是，PANOVA-3试验达到了总体生存的积极主要终点，这是该领域的一个里程碑式的结果，”医学肿瘤学家兼PANOVA-3试验研究者文森特·皮科齐（VincentPicozzi）说。

“These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.”.

“这些肿瘤治疗领域的数据非常有前景，特别是在这个难以治疗的患者群体中。”。

In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P =0.039) (N=571).

在意向治疗人群中，TTFields治疗联合吉西他滨和nab-紫杉醇治疗的患者的mOS为16.20个月，而单独使用吉西他滨和nab-紫杉醇治疗的患者的mOS为14.16个月，有统计学意义的2.0个月改善（风险比=0.819；P=0.039）（N=571）。

The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies. .

TTFields治疗患者的生存率随着时间的推移而增加，12个月时总生存率提高了13%，24个月时生存率提高了33%。TTFields治疗耐受性良好，安全性与先前的临床研究一致。

“PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years,” said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure.

Novocure首席医疗官Nicolas Leupin医学博士说：“PANOVA-3是第一个也是唯一一个在统计学上显着提高总体生存率的3期临床试验，特别是在不可切除的局部晚期胰腺癌中，并且是Novocure在过去两年中的第三个阳性3期临床试验。”。

“We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.”.

“我们感谢患者和研究人员参与试验，我们期待着在即将举行的医学会议上分享完整的数据。”。

Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress.

Novocure计划根据PANOVA-3在不可切除的局部晚期胰腺癌中申请TTFields的监管批准，并计划将PANOVA-3结果提交给即将举行的医学大会。

Novocure continues to follow patients in its Phase 2 PANOVA-4 trial, exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment with data anticipated in 2026.

Novocure在其2期PANOVA-4试验中继续跟踪患者，探索使用TTFields疗法与atezolizumab，吉西他滨和nab-紫杉醇联合治疗转移性胰腺癌。PANOVA-4已完成注册，预计2026年将有数据。

About PANOVA-3

关于PANOVA-3

PANOVA-3 is a prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone..

PANOVA-3是一项前瞻性，随机，开放标签，对照的3期临床试验，旨在测试与吉西他滨和nab-紫杉醇联合使用的肿瘤治疗场（TTFields）治疗的疗效和安全性，作为局部晚期胰腺癌的一线治疗。患者被随机分配接受TTFields治疗，同时接受吉西他滨和nab-紫杉醇或吉西他滨和nab-紫杉醇单独治疗。。

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

主要终点是总生存期。次要终点包括无进展生存期，局部无进展生存期，客观缓解率，一年生存率，生活质量，无疼痛生存期，无穿刺生存期，可切除率和毒性。

A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months.

共有571名患者参加了这项研究，按1:1随机分组，随访至少18个月。

About PANOVA-4

关于PANOVA-4

PANOVA-4 is an international, multi-center Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treating of metastatic pancreatic cancer. The primary endpoint is disease control rate.

PANOVA-4是一项国际多中心2期临床试验，旨在测试肿瘤治疗领域（TTFields）治疗与atezolizumab，吉西他滨和nab-紫杉醇联合治疗转移性胰腺癌的安全性和有效性。主要终点是疾病控制率。

Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response and toxicity. The study is designed to enroll 76 patients..

次要终点包括总生存期，无进展生存期，一年生存率，客观缓解率，六个月无进展生存期，缓解持续时间和毒性。该研究旨在招募76名患者。。

About Pancreatic Cancer

关于胰腺癌

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. 1 While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. 2 It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S.

胰腺癌是最致命的癌症之一，是美国第三大癌症死亡原因。1虽然总体癌症发病率和死亡率保持稳定或下降，但胰腺癌的发病率和死亡率正在上升。2据估计，美国每年约有67000名患者被诊断出患有胰腺癌。

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation.

医生根据疾病的阶段，使用不同的手术，放射和药物治疗组合来治疗胰腺癌。对于局部晚期胰腺癌患者，涉及动脉包裹但无胰腺外疾病，标准治疗是手术，然后进行化疗，有或没有放疗。

Unfortunately, most locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option..

不幸的是，一旦癌症不再可手术，大多数局部晚期病例就会被诊断出来，通常将有或没有放疗的化疗作为唯一的治疗选择。。

About Tumor Treating Fields

关于Tumor Treating Fields

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）。

These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these 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.

这些多种不同的机制共同作用以靶向和杀死癌细胞。由于这些多机制作用，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..

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。。

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com .

要了解更多关于TTFields疗法及其对癌细胞的多方面影响，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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma.

Novocure 是一家全球性肿瘤公司，致力于通过其创新疗法 “肿瘤治疗场 ”的开发和商业化，延长一些最具侵袭性癌症患者的生存期。Novocure 的商业化产品已在某些国家获得批准，用于治疗患有胶质母细胞瘤、非小细胞肺癌、恶性胸膜间皮瘤和胸膜间皮瘤的成年患者。

Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer..

Novocure还有几项正在进行或已完成的临床试验，探索使用肿瘤治疗场治疗胶质母细胞瘤，非小细胞肺癌和胰腺癌。。

Novocure’s global headquarters is located in Root Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter).

Novocure全球总部位于瑞士根，美国总部位于新罕布什尔州朴茨茅斯，研发设施位于以色列海法。有关该公司的更多信息，请访问Novocure.com，并在LinkedIn和X（Twitter）上关注@Novocure。