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Optune Pax CE Mark expands Novocure (NASDAQ: NVCR) pancreatic cancer reach

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Form Type
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Rhea-AI Filing Summary

Novocure reported that its wearable device Optune Pax, which delivers Tumor Treating Fields, has received a CE Mark to treat adult patients with locally advanced pancreatic cancer of exocrine origin when used with gemcitabine and nab-paclitaxel in line with guideline recommendations. The approval is backed by the Phase 3 PANOVA-3 trial, where patients in the intent-to-treat group receiving Optune Pax plus chemotherapy achieved a median overall survival of 16.2 months versus 14.2 months on chemotherapy alone, and a significant 6.1‑month extension in median time to pain progression. In the modified intent-to-treat group, median overall survival reached 18.3 months with Optune Pax versus 15.1 months on chemotherapy alone. Optune Pax was generally well-tolerated, with mainly mild to moderate skin events and no device-related deaths reported.

Positive

  • CE Mark secured for Optune Pax in locally advanced pancreatic cancer, supported by Phase 3 PANOVA-3 data showing statistically significant gains in median overall survival and time to pain progression versus chemotherapy alone, plus generally manageable safety with mostly mild to moderate skin-related adverse events.

Negative

  • None.

Insights

CE Mark plus positive Phase 3 data strengthens Novocure’s pancreatic cancer position.

The CE Mark for Optune Pax in locally advanced pancreatic cancer creates an approved European indication built on a randomized Phase 3 trial. PANOVA-3 enrolled 571 patients and met its primary endpoint with statistically significant median overall survival gains.

In the intent-to-treat group, median overall survival was 16.2 months with Optune Pax plus gem/nab-pac versus 14.2 months with chemotherapy alone, and the hazard ratio of 0.82 indicates a lower risk of death. The modified intent-to-treat population showed an even larger 3.2‑month survival improvement.

Pain control and quality-of-life data add clinical depth: time to pain progression improved from 9.1 to 15.2 months, and deterioration-free survival favored Optune Pax in several domains. Safety was mainly skin-related, with no device-related deaths. Future disclosures may clarify reimbursement and launch progress in Europe, including the planned launch in Germany.

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.
PANOVA-3 enrollment 571 patients International Phase 3 trial sample size
Median OS ITT, Optune Pax arm 16.2 months Intent-to-treat, Optune Pax + gem/nab-pac
Median OS ITT, control arm 14.2 months Intent-to-treat, gem/nab-pac alone
Median OS mITT, Optune Pax arm 18.3 months Modified intent-to-treat, Optune Pax + gem/nab-pac
Median OS mITT, control arm 15.1 months Modified intent-to-treat, gem/nab-pac alone
Median time to pain progression 15.2 vs 9.1 months Optune Pax + gem/nab-pac vs gem/nab-pac alone
One-year survival ITT 68.1% vs 60.2% Optune Pax + gem/nab-pac vs control
Skin AE incidence 76.3% of patients Optune Pax-treated participants with device-related skin AEs
CE Mark regulatory
"Optune Pax has received a CE (Conformité Européenne) Mark for the treatment of adult patients"
A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.
Tumor Treating Fields medical
"Optune Pax is a first-of-its-kind wearable medical device ... that delivers Tumor Treating Fields"
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.
PANOVA-3 medical
"The CE Mark is supported by results from the Phase 3 PANOVA-3 trial"
intent-to-treat population medical
"In the intent-to-treat population (ITT), patients treated with Optune Pax"
The intent-to-treat population is the set of all participants who were assigned to a treatment group when a clinical trial began, counted in the final analysis regardless of whether they completed the treatment or followed the protocol. For investors, this matters because results reported on this basis tend to show how a therapy performs in real-world use—providing a conservative, less biased measure of effectiveness that regulators and markets rely on when assessing risk and potential value. Think of it like grading a cooking class by everyone who signed up, not just those who finished the recipe.
progression-free survival medical
"There was no significant difference in additional secondary outcome measures of progression-free survival"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
quality of life (QoL) medical
"Quality of life (QoL) was a secondary endpoint measured at baseline and every 8 weeks"
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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 30, 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 30, 2026, the Company issued a press release announcing that that that Optune Pax® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with locally-advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations. Because the use of gemcitabine and nab-paclitaxel may vary by market, the approved CE Mark intended purpose for Optune Pax includes a reference to guideline recommendations to account for these local differences.

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 30, 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 30, 2026


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

Exhibit 99.1

Novocure’s Optune Pax® Receives CE Mark for the Treatment of Locally Advanced Pancreatic Cancer
The CE Mark is supported by results from the Phase 3 PANOVA-3 trial demonstrating a statistically significant improvement in overall survival (OS) for patients treated with Optune Pax concomitant with gemcitabine and nab-paclitaxel
Treatment with Optune Pax was also shown to significantly delay patients’ pain progression, helping to preserve quality of life
Optune Pax is a first-of-its-kind wearable medical device for the treatment of pancreatic cancer that delivers Tumor Treating Fields, alternating electric fields that cause cancer cell death
BAAR, Switzerland— June 30, 2026 —Novocure (NASDAQ: NVCR) announced today that Optune Pax® has received CE (Conformité Européenne) Mark for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations.
“Pancreatic cancer is often diagnosed in late stages when tumors are more difficult to treat. As a result, treatment options have limited effect and survival rates have remained low for decades. However, in the Phase 3 PANOVA-3 trial for Optune Pax, a statistically significant improvement in overall survival was observed in patients who were at an advanced stage of disease,” said Teresa Macarulla, MD, PhD, Head of the Department of Medical Oncology at Hospital Clínic Barcelona. “In addition, Optune Pax was also shown to delay pain progression, a debilitating symptom of pancreatic cancer. This is a promising treatment for patients who have an urgent need for new options.”
Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells.
The CE Mark for Optune Pax for locally advanced pancreatic cancer is supported by data from the Phase 3 PANOVA-3 clinical trial, which met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax and gem/nab-pac, compared to those patients who received gem/nab-pac alone, while also significantly extending time to pain progression, a key secondary endpoint. Because the use of gemcitabine and nab-paclitaxel may vary by market, the approved CE Mark intended purpose for Optune Pax includes a reference to guideline recommendations to account for these local differences.
“The CE Mark designation is a critical milestone in our efforts to bring Optune Pax to people living with locally advanced pancreatic cancer, a disease in need of new treatment options,” said Anne Calixte de Lembeye, Senior Vice President, EMEA and Canada, Novocure. “We are proud of this achievement and are committed to working with national agencies to secure access to Optune Pax for patients with pancreatic cancer who may benefit from treatment.”
Data Supporting the CE Mark of Optune Pax in Locally Advanced Pancreatic Cancer
PANOVA-3 was an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to evaluate the use of Optune Pax concomitant with gem/nab-pac as a first-line treatment for locally advanced pancreatic cancer compared to gem/nab-pac alone.

Exhibit 99.1
The trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. The trial met its primary endpoint, demonstrating a statistically significant improvement in mOS for patients treated with Optune Pax.
•In the intent-to-treat population (ITT), patients treated with Optune Pax concomitantly with gem/nab-pac (n=285) had an mOS of 16.2 months [95% confidence interval (CI) 15.0–18.0] compared to 14.2 months (95% CI 12.8–15.4) for patients treated with gem/nab-pac alone (n=286), a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; (95% CI 0.68–0.99) p=0.039].
•In the modified intent-to-treat (mITT) population, defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac or at least one complete cycle of gem/nab-pac, patients treated with Optune Pax concomitantly with gem/nab-pac (n=198) had an mOS of 18.3 months (95% CI 16.1–20.0) compared to 15.1 months (95% CI 13.4–17.0) in those treated with gem/nab-pac alone (n=207), a statistically significant 3.2-month improvement [HR 0.77; (95% CI 0.62–0.97) p=0.023].
Optune Pax concomitant with gem/nab-pac demonstrated improvement in several secondary endpoints, including the one-year survival rate.
•The one-year survival rate in the ITT population showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 68.1% [95% CI 62.0–73.5] compared to those who received gem/nab-pac alone, 60.2% [95% CI 54.2–65.7].
•In the mITT population, the one-year survival rate showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 75.2% (95% CI 68.5–80.7) compared to 65.9% (95% CI 59.0–72.0) in patients who received gem/nab-pac alone.
Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge. In PANOVA-3, time to pain progression was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual analogue scale for pain or until death.
•Patients treated with Optune Pax concomitant with gem/nab-pac had a median time to pain progression of 15.2 months (95% CI 10.3–22.8) compared to a median 9.1 months in the group treated with gem/nab-pac alone (95% CI 7.4–12.7). This is a significant 6.1-month extension in time to pain progression [HR 0.74; (95% CI 0.56–0.97) p=0.027].
Quality of life (QoL) was a secondary endpoint measured at baseline and every 8 weeks. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer-specific PAN26 addendum. Treatment with Optune Pax concomitant with gem/nab-pac resulted in longer deterioration-free survival (DFS) in global health status, pain, pancreatic pain and most of the digestive problems. Similar trends were observed for emotional function and fatigue/lack of energy.
There was no significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the Optune Pax concomitant with gem/nab-pac and the gem/nab-pac alone arms.
Optune Pax was well-tolerated and did not exacerbate gem/nab-pac -related systemic toxicity, no new safety signals were observed, and serious adverse events (SAEs) were comparable between study arms. Most Optune Pax-treated patients experienced the expected device-related skin

Exhibit 99.1
adverse events (AEs) under the arrays (76.3% of the Optune Pax-treated participants). The majority of these events were mild to moderate (Grade 1-2), with 21 (7.7%) experiencing a Grade ≥3 event. The most common device-related AE not related to skin AEs was fatigue, reported in 14 participants (5.1%). There was one Grade 4 AE suspected to be related to the device by the investigator, which was a non-serious event of neutrophil count decrease. There were no device-related AEs that led to death, and no unanticipated device-related safety issues during the study.
The results from the Phase 3 PANOVA-3 trial were published in the Journal of Clinical Oncology, available online at https://ascopubs.org/doi/10.1200/JCO-25-00746.
Optune Pax was approved by the U.S. Food and Drug Administration in February 2026.
Novocure plans to launch Optune Pax in Germany in the coming weeks.
About Pancreatic Cancer
According to the World Health Organization (WHO), pancreatic cancer is one of the most lethal cancers and is the fifth most frequent cause of death from cancer in Europe.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 in Europe approximately 146,000 patients are diagnosed with pancreatic cancer each year.3 Pancreatic cancer has a five-year relative survival rate of just 13%.4
Physicians use different combinations of surgery, radiation, and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. Unfortunately, most locally advanced pancreatic cancer cases are diagnosed when the cancer is no longer operable, meaning encasement of blood vessels, but no extra-pancreatic disease, leaving few treatment options. The standard of care for locally advanced pancreatic cancer is chemotherapy with or without radiation, and surgery if it is possible.
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.
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

Exhibit 99.1
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 trial 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 “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.
____________________________
1 International Agency for Research on Cancer. 2024. Cancer Today (GLOBOCAN 2022). https://gco.iarc.who.int/today/en/dataviz/tables?mode=cancer&group_populations=1&populations=908&multiple_populations=1&types=1 Accessed on June 16, 2026.
2 American Cancer Society. Cancer Facts & Figures 2025. 1930;(500825). https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf Accessed January 16, 2026.
3 International Agency for Research on Cancer. 2024. Cancer Today (GLOBOCAN 2022). https://gco.iarc.who.int/today/en/dataviz/tables?mode=cancer&group_populations=1&populations=908&multiple_populations=1&types=0 Accessed on June 16, 2026.
4 American Cancer Society. Cancer Facts & Figures 2026. Atlanta: American Cancer Society; 2026

Investors: Adam Daneyinvestorinfo@novocure.com
Media: Joachim Horschitzmedia@novocure.com

Source: View Original Filing on SEC EDGAR

FAQ

What did Novocure (NVCR) announce about Optune Pax in this 8-K?

Novocure announced that Optune Pax received a CE Mark for treating adult patients with locally advanced pancreatic cancer of exocrine origin when used with gemcitabine and nab-paclitaxel, in accordance with guideline recommendations across European markets.

What were the key survival results from Novocure’s PANOVA-3 trial?

In the intent-to-treat group, patients on Optune Pax plus gem/nab-pac had median overall survival of 16.2 months versus 14.2 months on chemotherapy alone, a statistically significant 2.0‑month improvement with a hazard ratio of 0.82 and p-value of 0.039.

How did Optune Pax affect outcomes in the modified intent-to-treat population?

In the modified intent-to-treat group, median overall survival was 18.3 months for Optune Pax plus gem/nab-pac versus 15.1 months for chemotherapy alone. This represented a statistically significant 3.2‑month benefit with a hazard ratio of 0.77 and p-value of 0.023.

What impact did Optune Pax have on pancreatic cancer pain in PANOVA-3?

Patients treated with Optune Pax plus gem/nab-pac had a median time to pain progression of 15.2 months compared with 9.1 months for chemotherapy alone, a significant 6.1‑month extension, with a hazard ratio of 0.74 and p-value of 0.027.

Were there any notable safety concerns with Optune Pax in the trial?

Optune Pax was generally well-tolerated. About 76.3% of Optune Pax-treated patients experienced expected skin adverse events under the arrays, mostly Grade 1–2, with 7.7% Grade ≥3, one Grade 4 neutrophil decrease, and no device-related deaths or unanticipated safety issues.

What are Tumor Treating Fields (TTFields) used by Optune Pax?

Tumor Treating Fields are alternating electric fields that disrupt processes critical for cancer cell division and survival, leading to cancer cell death. Because healthy cells have different properties, TTFields are designed to spare them, allowing Optune Pax to act as a non-invasive, wearable cancer therapy.

Where does Novocure plan to launch Optune Pax after this CE Mark?

Novocure stated it plans to launch Optune Pax in Germany in the coming weeks. The company also intends to work with national agencies across Europe to secure patient access for those with locally advanced pancreatic cancer who may benefit from treatment.

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