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重大事件 即時報告 8-K 2026-06-18

NovoCure 公佈第三期 TRIDENT 試驗頂線結果:未達統計學顯著改善

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📢 **NovoCure 公佈第三期 TRIDENT 試驗頂線結果:未達統計學顯著改善** (申報類型:8-K,日期:2026年6月18日) 腫瘤治療場(TTFields)療法開發商 NovoCure Limited (NASDAQ: NVCR) 於 6 月 18 日發佈新聞稿,公佈其第三期關鍵性 TRIDENT 試驗的頂線結果。該試驗旨在評估在新診斷膠質母細胞瘤(GBM)患者中,於化放療開始時即啟動 TTFields 治療(「早期啟動組」),對比在化放療完成後、於維持治療階段才啟動 TTFields(「維持啟動組」)的療效與安全性。 **主要結果** - 試驗未達到主要終點——總生存期(OS)的統計學顯著改善。在意向治療(ITT)人群中,早期啟動組中位 OS 為 17.7 個月,維持啟動組為 17.5 個月(風險比 HR=0.953,p=0.519)。 - 次要終點(如無進展生存期、客觀緩解率等)的詳細數據將於後續學術會議公佈。 - 安全性方面:TTFields 治療(包括與化放療同步使用)耐受性良好,未出現新的安全性信號,設備相關不良事件與過往 GBM 臨床研究一致。 **試驗背景** TRIDENT 是一項全球性、隨機、開放標籤、多中心的第三期試驗,共納入新診斷 GBM 患者。兩組患者在化放療後均繼續接受 TTFields 及維持期替莫唑胺化療。該試驗結果已被接受於 2026 年美國放射腫瘤學會(ASTRO)年會上發佈。 **對投資者的潛在影響** - 本次負面結果可能令市場對 TTFields 在 GBM 一線治療中的應用前景產生疑慮,短期內股價或受壓。 - 然而,試驗確認了 TTFields 與化放療同步使用的安全可行性,並無超預期毒性;未來仍需關注其他適應症(如非小細胞肺癌、卵巢癌等)的數據進展。 - NovoCure 將繼續分析亞組數據,並探索可能受益的患者群體。管理層尚未就 TRIDENT 結果對商業策略或監管提交的影響作出具體指引。 (本次 8-K 申報僅供參考,不構成《交易所法》第 18 條意義上的「存檔」,亦不視為納入任何其他 SEC 申報文件。)
展開英文正文
nvcr-202606180001645113false00016451132026-06-012026-06-30

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K 
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

June 18, 2026 
Date of Report (date of earliest event reported)

NovoCure Limited 
(Exact name of registrant as specified in its charter)

Jersey
001-3756598-1057807

(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

No. 4 The Forum, Grenville Street
St. Helier
Jersey
JE2 4UF

(Address of Principal Executive Offices)
(Zip Code)

+44 (0) 15 3475 6700 
Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Act: 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares, no par valueNVCRThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐ 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
o

Item 7.01     Regulation FD Disclosure. 

On June 18, 2026, the Company issued a press release announcing top line results from its Phase 3 TRIDENT trial, which evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) at the start of chemoradiation (Early Start Arm) compared to initiating TTFields therapy during the subsequent maintenance phase of treatment (Maintenance Start Arm). 

The trial did not demonstrate a statistically significant improvement in the primary endpoint of overall survival for the Early Start Arm compared to the Maintenance Start Arm. In the intent-to-treat (ITT) population, the Early Start Arm had a median overall survival of 17.7 months compared to 17.5 months in Maintenance Start Arm (HR 0.953; p=0.519). 

TTFields therapy, including initiation with chemoradiation, was well-tolerated, and did not lead to any new safety signals. Device related safety was consistent with prior clinical studies of TTFields therapy in GBM.

The results from TRIDENT have been accepted for presentation at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting.

TRIDENT is a Phase 3 global, pivotal, randomized, open-label, two-arm, multicenter trial designed to evaluate the effectiveness and safety of TTFields therapy given concomitantly with chemoradiation (radiation therapy and temozolomide), for newly diagnosed GBM patients, compared to initiating TTFields therapy once chemoradiation therapy is complete. In both arms, TTFields therapy and maintenance temozolomide are continued following chemoradiation therapy. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival, one-, two- and three survival rates, overall radiologic response (ORR) based on the 2010 Response Assessment in Neuro-Oncology (RANO) criteria, next progression free survival, based on the 2010 RANO criteria and progression-free survival at 6 months and 12 months, and the severity and frequency of adverse events. RANO guidelines are an international, multidisciplinary set of recommendations designed to standardize the evaluation of treatment response in clinical trials for brain tumors.

The information contained in this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d)    Exhibits

Exhibit No.Description

99.1Press Release of NovoCure Limited, dated June 18, 2026

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

NovoCure Limited
(Registrant)

Date: June 18, 2026

By: /s/ Christoph Brackmann 
 Name: Christoph Brackmann
 Title: Chief Financial Officer