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Novocure (NASDAQ: NVCR) Phase 3 TRIDENT glioblastoma study misses survival endpoint

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Novocure reported topline data from its Phase 3 TRIDENT trial in newly diagnosed glioblastoma. The study tested starting Tumor Treating Fields (TTFields) at the beginning of chemoradiation versus starting during the maintenance phase.

The trial did not show a statistically significant improvement in the primary endpoint of overall survival for early initiation. Median overall survival in the intent-to-treat group was 17.7 months in the Early Start Arm versus 17.5 months in the Maintenance Start Arm (HR 0.953; p=0.519). One-, two- and three-year survival rates were similar between arms.

TTFields therapy, including initiation with chemoradiation, was well-tolerated with no new safety signals, and device-related safety remained consistent with prior TTFields studies in glioblastoma. Results have been accepted for presentation at the ASTRO 2026 Annual Meeting.

Positive

  • TTFields safety reaffirmed: Therapy, including initiation with chemoradiation, was well-tolerated with no new safety signals, and device-related safety was consistent with prior glioblastoma studies.

Negative

  • TRIDENT primary endpoint not met: Early initiation of Tumor Treating Fields did not produce a statistically significant improvement in overall survival versus starting during maintenance (HR 0.953; p=0.519).

Insights

Phase 3 TRIDENT missed its primary endpoint, limiting upside from earlier TTFields use but reinforcing safety.

The TRIDENT trial tested whether starting Tumor Treating Fields at the beginning of chemoradiation improved outcomes versus starting in the maintenance phase for newly diagnosed glioblastoma. Median overall survival was 17.7 months for early start versus 17.5 months for maintenance start (HR 0.953; p=0.519), so the primary endpoint was not met.

This outcome reduces expectations that earlier TTFields initiation alone will meaningfully extend survival in an unselected population. However, both arms showed durable survival rates over three years, and safety, including device-related events, was consistent with prior experience, which helps support the existing clinical profile of TTFields therapy.

Management highlights feasibility and tolerability of combining TTFields with chemoradiation and points to potential benefits in selected patients, suggesting future subgroup and exploratory analyses will be important for understanding where earlier use may still add value within the broader TTFields portfolio.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Median OS Early Start 17.7 months Intent-to-treat population, Early Start Arm overall survival
Median OS Maintenance Start 17.5 months Intent-to-treat population, Maintenance Start Arm overall survival
Hazard ratio 0.953 Early versus Maintenance Start Arms, overall survival primary endpoint
P-value 0.519 Primary endpoint statistical comparison of overall survival
TRIDENT enrollment 981 patients Newly diagnosed glioblastoma patients randomized shortly after surgery
1-year survival Early Start 70.9% One-year survival rate in Early Start Arm
1-year survival Maintenance 72.0% One-year survival rate in Maintenance Start Arm
Patients not initiating maintenance ≈25% Proportion of enrolled patients who did not start maintenance phase
Tumor Treating Fields medical
"evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma"
Tumor treating fields are a medical therapy that uses low‑intensity, alternating electric fields applied through pads on the skin to interfere with cancer cells as they try to divide, slowing or stopping tumor growth. Investors pay attention because the therapy’s clinical results, regulatory approvals, reimbursement and device sales directly influence a company’s revenue outlook; think of it like a new tool in a toolbox whose market adoption and proof it works determine its commercial value.
glioblastoma medical
"Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM)"
Glioblastoma is a fast-growing and aggressive type of brain tumor that can affect a person's thinking, movement, or senses. Its seriousness and difficulty to treat can lead to significant health impacts, making it a concern for medical research and drug development. For investors, advances or setbacks in glioblastoma treatments can influence biotech companies and healthcare markets focused on cancer therapies.
intent-to-treat (ITT) population medical
"In the intent-to-treat (ITT) population, the Early Start Arm had a median overall survival"
The intent-to-treat (ITT) population includes every person who was assigned to a treatment or control group in a clinical trial, and they are analyzed according to that original assignment regardless of whether they completed the treatment or followed the protocol. For investors, ITT results give a conservative, real-world view of how a therapy performs and reduce bias—like judging a class by the students originally enrolled rather than only those who finished the course—helping assess the reliability of trial-backed claims.
overall survival medical
"did not demonstrate a statistically significant improvement in the primary endpoint of overall survival"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
Response Assessment in Neuro-Oncology (RANO) medical
"overall radiologic response (ORR) based on the 2010 Response Assessment in Neuro-Oncology (RANO) criteria"
Response Assessment in Neuro-Oncology (RANO) is a standardized set of rules researchers and doctors use to judge whether brain tumors are shrinking, stable, or growing after treatment, based on scans and clinical signs. It matters to investors because RANO outcomes are a common benchmark in clinical trials that influence regulatory decisions, perceived drug effectiveness, and commercial prospects — think of it as the scorecard investors use to compare and value cancer therapies.
Phase 3 global, pivotal, randomized, open-label trial medical
"TRIDENT is a Phase 3 global, pivotal, randomized, open-label, two-arm, multicenter trial"
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0001645113false00016451132026-06-012026-06-30


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
001-37565
98-1057807
(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
99.1
Press 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

Exhibit 99.1
Novocure Announces Topline Data from the Phase 3 TRIDENT Trial Evaluating Earlier Use of Tumor Treating Fields Therapy in Newly Diagnosed Glioblastoma

The Phase 3 TRIDENT trial enrolled patients with glioblastoma prior to the initiation of chemoradiation and evaluated the benefit of initiating Tumor Treating Fields (TTFields) therapy at the start of chemoradiation compared to initiating TTFields therapy in the maintenance phase

TRIDENT did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival for patients in the intent-to-treat (ITT) population who initiated TTFields therapy at the start of chemoradiation

Results from TRIDENT demonstrated a durable survival benefit for patients in both arms of the trial, no new safety signals were observed, and early initiation of TTFields therapy was feasible

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

BAAR, Switzerland— June 17, 2026 — Novocure (NASDAQ: NVCR) announced topline results today 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 the Maintenance Start Arm (HR 0.953; p=0.519).

“TRIDENT represents the largest glioblastoma trial focused on optimizing the integration of Tumor Treating Fields therapy into standard chemoradiotherapy,” said Wenyin Shi, MD, PhD, Professor of Radiation Oncology, Co-Director of the Jefferson Brain Tumor Center at Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University. “Although the study did not meet its primary endpoint, it reaffirmed the clinical value of Tumor Treating Fields therapy and demonstrated promising signals that earlier initiation of TTFields treatment may improve outcomes for selected patients.”

The survival results in the ITT population in both study arms were durable over a long-term period with the one-, two-, and three-year survival rates in the Early Start Arm achieving 70.9%, 33.9% and 22.5%, respectively. In the Maintenance Start Arm, the survival rates were 72.0%, 31.6% and 18.4%, respectively.

TRIDENT enrolled 981 patients who were randomized shortly after surgery, including those who experienced clinical or radiographic deterioration during chemoradiation therapy. Approximately 25% of patients did not initiate the maintenance phase across both arms of the trial. The median patient age was 60 years. Baseline characteristics of the patient population were balanced across both arms of the trial and included: 38% of patients with


Exhibit 99.1
a KPS of 70 or 80; 39% with a methylated MGMT promoter and 5% had IDH-mutant tumors. The extent of surgical resection was also balanced across arms, 51% of patients had a gross total resection, 37% a partial resection, and 12% biopsy only.

“We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “The study did not meet its primary endpoint, but the results from TRIDENT demonstrated the feasibility and safety of initiating Tumor Treating Fields therapy during chemoradiation. We look forward to sharing additional analyses from this trial, which may inform future treatment approaches for patients with specific characteristics.”

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.

About TRIDENT

TRIDENT is a Phase 3 global, pivotal, randomized, open-label, two-arm, multicenter trial designed to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) therapy given concomitantly with chemoradiation (radiation therapy and temozolomide), for newly diagnosed glioblastoma 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-year 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.

About 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. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.



Exhibit 99.1
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

About 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, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. 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’s global headquarters is located in Baar, 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).

Forward-Looking Statements

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. You may identify some of these forward-looking statements by the use of words in the statements such as “could” “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 26, 2026, and subsequent filings with the U.S. 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. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

# # #

Investors:
Adam Daney
investorinfo@novocure.com



Exhibit 99.1
Media:
Catherine Falcetti
media@novocure.com

FAQ

What did Novocure (NVCR) announce about the Phase 3 TRIDENT trial?

Novocure announced topline results showing the TRIDENT trial did not meet its primary endpoint. Starting Tumor Treating Fields therapy at the beginning of chemoradiation did not significantly improve overall survival versus starting during the maintenance phase in newly diagnosed glioblastoma.

What were the overall survival results in Novocure’s TRIDENT trial (NVCR)?

Median overall survival was similar between the two TRIDENT trial arms. In the intent-to-treat population, the Early Start Arm had a median overall survival of 17.7 months versus 17.5 months in the Maintenance Start Arm, with a hazard ratio of 0.953 and p=0.519.

Were there any new safety concerns with Tumor Treating Fields in TRIDENT for NVCR?

No new safety signals were observed in the TRIDENT trial. Tumor Treating Fields therapy, including when initiated with chemoradiation, was well-tolerated, and device-related safety findings were consistent with prior clinical studies of Tumor Treating Fields therapy in glioblastoma.

How many patients were enrolled in Novocure’s TRIDENT Phase 3 trial?

The TRIDENT trial enrolled 981 patients with newly diagnosed glioblastoma. Patients were randomized shortly after surgery, and approximately 25% across both study arms did not initiate the maintenance phase of treatment during the course of the trial.

What secondary outcomes were evaluated in the TRIDENT trial reported by NVCR?

TRIDENT assessed several secondary endpoints beyond overall survival. These included progression-free survival, one-, two-, and three-year survival rates, radiologic response using 2010 RANO criteria, next progression-free survival, progression-free survival at 6 and 12 months, and the severity and frequency of adverse events.

Will Novocure present the TRIDENT results at a medical meeting?

Yes, TRIDENT results have been accepted for presentation at ASTRO 2026. The American Society for Radiation Oncology 2026 Annual Meeting will feature the Phase 3 data, providing clinicians and researchers with more detailed analyses of efficacy and safety outcomes.

Filing Exhibits & Attachments

4 documents