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    Novocure to Present Final Secondary Endpoint Data from the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) in Pancreatic Cancer at the ESMO Gastrointestinal Cancers Congress 2025

    7/1/25 7:00:00 AM ET
    $NVCR
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    TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated a statistically significant and clinically meaningful benefit across multiple measures of pain and in a post-hoc analysis significantly delayed the need for opioid pain medication for patients with unresectable, locally advanced pancreatic adenocarcinoma

    A significant delay in deterioration across measures of health status was observed, preserving quality of life longer in patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel

    These data complement the previously reported overall survival benefit seen in PANOVA-3, supporting TTFields concomitant with gemcitabine and nab-paclitaxel as a potential new therapeutic option for unresectable, locally advanced pancreatic cancer

    Novocure (NASDAQ:NVCR) announced today that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer. These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain.

    "In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient's overall quality of life, a promising outcome we observed in this trial," said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d'Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d'Hebron Institute of Oncology (VHIO). "The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer."

    The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.

    "The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients' quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025."

    Results from PANOVA-3

    The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

    The additional secondary endpoint data to be presented at the ESMO Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use.

    The quality of life outcomes were measured 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 scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms.

    There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023.

    The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003.

    Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006.

    These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027.

    All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP.

    In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046.

    TTFields therapy was well-tolerated, no new safety signals were observed, and device related safety outcomes were consistent with prior clinical studies using TTFields. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

    The company will also present two posters of preclinical data from its pancreatic cancer development program.

    Data Presentation Details

    Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC)

    Presenting Author: Teresa Macarulla, MD, PhD, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Spain

    Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room

    Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models

    Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

    Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields)

    Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

    About PANOVA-3

    PANOVA-3 is an international, 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 for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

    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.

    The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

    About Pancreatic Cancer

    Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S.i and the fifth most frequent cause in Europe.ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S.iv and the global incidence is more than 500,000.v Pancreatic cancer has a five-year relative survival rate of just 13%.vi

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

    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 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. 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 tumortreatingfields.com.

    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, 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 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 27, 2025, 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.

    i American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025

    ii International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. https://gco.iarc.who.int/today/en/dataviz/bars?types=1&mode=cancer&group_populations=1&sort_by=value0&populations=908. Accessed June 24, 2025.

    iii American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025

    iv American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025

    v International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. https://gco.iarc.who.int/today/en/dataviz/pie?mode=population&group_populations=0&cancers=13&types=0&show_table_pie=1. Accessed June 24, 2025.

    vi American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025

    View source version on businesswire.com: https://www.businesswire.com/news/home/20250701025828/en/

    Investors:

    Ingrid Goldberg

    [email protected]

    Media:

    Catherine Falcetti

    [email protected]

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