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Business Wire
24-07-2025
- Business
- Business Wire
Novocure Reports Second Quarter 2025 Financial Results
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today reported financial results for the second quarter that ended June 30, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). 'With the first half of 2025 complete, I am pleased to report continued progress towards our clinical, regulatory and commercial milestones. In Q2, we grew our glioblastoma and non-small cell lung cancer businesses and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations,' said Ashley Cordova, CEO, Novocure. 'With one launch ongoing and two more on the horizon, we are well-positioned in both the near and long term. This is a pivotal period for Novocure.' Financial updates for the second quarter ended June 30, 2025: Total net revenues for the quarter were $158.8 million, an increase of 6% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets. The U.S., Germany, France and Japan contributed $94.3 million, $19.1 million, $18.4 million and $9.5 million, respectively, with other active markets contributing $13.0 million. Revenue in Greater China from Novocure's partnership with Zai Lab totaled $4.6 million. Recognized revenue from Optune Lua ® in the quarter was $2.4 million, including $1.1 million from non-small cell lung cancer (NSCLC) and $1.3 million from malignant pleural mesothelioma (MPM). Gross margin for the quarter was 74% compared to 77% in the prior year. The reduction of gross margin was primarily driven by the roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio ®, the NSCLC launch where we are treating on-label patients at risk prior to establishing broad reimbursement, and increased tariffs. Research, development and clinical studies expenses for the quarter were $55.8 million, an increase of 2% from the same period in 2024. This was primarily driven by increased direct clinical trial expenses related to the ramp of the LUNAR-2 and KEYNOTE D58 trials. Sales and marketing expenses for the quarter were $57.1 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force. General and administrative expenses for the quarter were $44.0 million, an increase of 17% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the NSCLC launch and general company build-out, particularly on the enterprise technology side. Net loss for the quarter was $40.1 million with loss per share of $0.36. Adjusted EBITDA* for the quarter was $(9.9) million. Cash, cash equivalents and short-term investments were $911.5 million as of June 30, 2025. Operational updates for the second quarter ended June 30, 2025: As of June 30, 2025, there were 4,331 total active patients on TTFields therapy globally. Optune Gio 1,598 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 963; 199; 179 and 101 prescriptions, respectively, with the remaining 156 prescriptions contributed by other active markets. As of June 30, 2025, there were 4,194 Optune Gio active patients on therapy, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,177; 581; 453 and 451 Optune Gio active patients, respectively, with the remaining 532 active patients contributed by other active markets. Optune Lua 143 total prescriptions for Optune Lua were received in the quarter. 121 Optune Lua prescriptions were received for the treatment of NSCLC and 22 prescriptions were received for the treatment of MPM. As of June 30, 2025, there were 137 active Optune Lua patients on therapy, including 94 patients treated for metastatic NSCLC and 43 patients treated for MPM. Quarterly updates and achievements: In May 2025, Novocure presented the results of the Phase 3 PANOVA-3 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. PANOVA-3 met its primary endpoint, demonstrating a statistically significant extension in overall survival in patients treated with TTFields therapy together with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. Patients treated with TTFields therapy also exhibited a statistically significant extension in pain-free survival (secondary endpoint) and distant progression-free survival (post hoc analysis). The presentation was selected for inclusion in 'Best of ASCO' program and the data were simultaneously published in the Journal of Clinical Oncology. In July 2025, Novocure presented final quality of life data from the PANOVA-3 trial at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025. Patients treated with TTFields therapy demonstrated a statistically significant and clinically meaningful benefit across multiple quality of life measures of pain (secondary endpoint) and significantly delayed the need for opioid pain medication (post hoc analysis) 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. Anticipated clinical and regulatory milestones: Novocure plans the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the treatment of unresectable, locally advanced pancreatic cancer based on results of the Phase 3 PANOVA-3 clinical trial in Q3 2025. Novocure plans the submission of a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in H2 2025. The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in H1 2026. The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in H1 2026. Conference call details Novocure will host a conference call and webcast to discuss second quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, July 24, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure's website, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. 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 and follow @Novocure on LinkedIn and X (Twitter). *Non-GAAP Financial Measurements We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation. 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. Consolidated Balance Sheets USD in thousands (except share data) NOVOCURE LIMITED AND SUBSIDIARIES U.S. dollars in thousands (except share data) June 30, 2025 December 31, 2024 Unaudited Audited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 149,624 $ 163,767 Short-term investments 761,901 796,106 Restricted cash 2,509 2,327 Trade receivables, net 89,915 74,226 Receivables and prepaid expenses 39,139 35,063 Inventories 40,211 35,086 Total current assets 1,083,299 1,106,575 LONG-TERM ASSETS: Property and equipment, net 80,333 77,660 Field equipment, net 18,591 14,811 Right-of-use assets 48,089 27,120 Other long-term assets 15,563 14,618 Total long-term assets 162,576 134,209 TOTAL ASSETS $ 1,245,875 $ 1,240,784 Expand Consolidated Balance Sheets USD in thousands (except share data) Non-U.S. GAAP Financial Measures Reconciliation USD in thousands Active Patients on Therapy June 30, 2025 2024 Optune Gio Optune Lua Total Optune Gio Optune Lua Total Active patients at period end (1) United States 2,177 98 2,275 2,163 12 2,175 International markets: Germany 581 33 614 527 11 538 France 453 — 453 369 — 369 Japan 451 — 451 403 — 403 Other international 532 6 538 475 3 478 International markets - Total 2,017 39 2,056 1,774 14 1,788 4,194 137 4,331 3,937 26 3,963 Expand (1) Optune Lua includes both active patients in NSCLC and MPM. Worldwide, there were 43 and 25 active MPM patients on therapy as of June 30, 2025 and 2024 and 94 and 1 active NSCLC patient(s) on therapy as of June 30, 2025 and 2024. Expand Important Safety Information What is Optune Gio ® approved to treat? Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older. Newly diagnosed GBM If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if: Your cancer is confirmed by your healthcare professional AND You have had surgery to remove as much of the tumor as possible Recurrent GBM If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if: You have tried surgery and radiation and they did not work or are no longer working AND You have tried chemotherapy and your GBM has been confirmed by your healthcare professional Who should not use Optune Gio? Optune Gio is not for everyone. Talk to your doctor if you have: An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy. What should I know before using Optune Gio? Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ®, the maker of Optune Gio. Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment What are the possible side effects of Optune Gio? Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions. Please visit for Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions. Important Safety Information What is Optune Lua ® approved to treat? Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Who should not use Optune Lua? Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have: An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy. What should I know before using Optune Lua? Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ®, the maker of Optune Lua. Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it's connected If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment. What are the possible side effects of Optune Lua? The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing). Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions.
Yahoo
08-07-2025
- Health
- Yahoo
Hope on the Horizon: Cutting-Edge Therapies Redefine Outcomes in Glioblastoma Multiforme Treatment making the global market to nearly double by 2033 and grow with a CAGR of 8.5%
The glioblastoma multiforme treatment market is expected to grow significantly and reach USD 6.1 billion by 2033, driven by a rising prevalence, growing R&D investment in novel therapies and favorable reimbursement support. New vaccine-based approaches are emerging as key areas of focus. Chicago, July 08, 2025 (GLOBE NEWSWIRE) -- The global glioblastoma multiforme treatment market was valeud at US$ 3.0 billion in 2024 and is expected to reach USD 6.1 billion by 2033, growing at a CAGR of 8.5% from 2025-2033. This expansion is fueled by rising disease prevalence, advances in diagnostics, growing R&D investments, and emerging targeted therapies. However, challenges such as the blood-brain barrier, therapeutic resistance, and limited long-term efficacy constrain progress and deter commercial investment. Despite these hurdles, innovation across therapeutic modalities and supportive technologies is gradually reshaping the treatment landscape. Explore Key Data Points and Forecast Tables in the Free Sample Copy: Glioblastoma Multiforme is the most common type of cancerous brain tumor. It poses significant treatment challenges due to its rapid proliferation, invasive growth, and resistance to conventional therapies. It is characterized by necrosis, microvascular proliferation, and marked cellular atypia. As per the American Association of Neurological Surgeons in 2024, glioblastoma multiforme accounted for 47.7% of malignant brain and CNS tumors, with an incidence of 3.2 per 100,000 and a prevalence of 9.2 per 100,000 in the U.S. According to the National Brain Tumor Society, the median survival is 14.6 months, with only 17% of patients alive after two years and a five-year survival rate of just 6.8%. It is more common in males, peaks between ages 75 – 84, and shows racial disparities, with highest incidence among non-Hispanic white populations. Treatment typically involves surgical resection followed by chemoradiation with temozolomide, which remains the standard of care (SoC). However, recurrence occurs in over 90% of patients within two years. For recurrent cases, bevacizumab (Avastin) and combinations like lomustine-bevacizumab offer modest benefits. Device-based therapies, such as Tumor Treating Fields (TTFields), continue gaining traction with FDA-approved systems like Optune Gio. Novel therapies, including selinexor (NCT04216329) and immune checkpoint inhibitors like nivolumab (NCT04606316), are currently in clinical trials, signaling progress towards durable Forecast (2033) USD 6.1 billion CAGR 8.5% Top Driver (s) Growing Prevalence of glioblastoma multiformeFavorable reimbursement policies Demand for effective treatment Top Trend Adoption of TTFields devices Top Restraint Consistently low survival rates in glioblastoma multiforme Opportunity Unlocked: Glioblastoma Vaccines as the Next Frontier in Immunotherapy Glioblastoma multiforme is hard to treat with conventional therapies. However, breakthroughs in vaccine-based immunotherapy are beginning to reshape the therapeutic landscape, offering new hope for the patients. Research efforts are accelerating around multiple vaccine platforms, including peptide-based, dendritic cell (DC), and mRNA vaccines, highlighting a new era of personalized and immune-driven treatment strategies. Peptide vaccines, such as SurVaxM developed by MimiVax and currently in Phase II clinical trials, are designed to target tumor-specific neoantigens, activating the immune system to selectively attack malignant cells. These personalized vaccines have shown potential in extending progression-free survival and enhancing immune engagement. Similarly, DC vaccines are gaining traction, despite logistical challenges in integration with standard therapies. Notable candidates such as DCVax-L, in Phase III trials for newly diagnosed and recurrent glioblastoma multiforme, and DOC1021, currently in Phase II trials by Diakonos, have demonstrated improved two-year survival rates when administered sequentially after temozolomide (TMZ) chemotherapy, rather than concurrently. Meanwhile, mRNA-based vaccines are emerging as a powerful immunotherapeutic modality, leveraging their rapid development cycle and capacity to induce strong, targeted immune responses against glioblastoma multiforme cells. Their adaptability and precision position them as a key component in next-generation oncology protocols. While the momentum is promising, ongoing research aims to refine delivery systems, address tumor-induced immunosuppression, and explore synergistic combinations with checkpoint inhibitors and standard-of-care therapies. Collectively, the expanding pipeline of glioblastoma vaccines signifies a paradigm shift toward more personalized, immune-based interventions, marking a transformative step forward in the quest for more durable and effective glioblastoma multiforme treatment. Regional Dynamics Shaping the Glioblastoma Multiforme Treatment Landscape The global glioblastoma multiforme treatment market is evolving rapidly, with regional dynamics playing a pivotal role in shaping its growth. North America leads the market, driven by advanced healthcare infrastructure, streamlined regulatory frameworks, and strong R&D investment. The U.S. Consolidated Appropriations Act of 2024 allocated $10 million to establish the Glioblastoma Research Program (GBMRP) under CDMRP, while Canada's Lundin Cancer Fund committed $4 million in 2025 to launch a national glioblastoma multiforme initiative, reinforcing the region's leadership in clinical innovation. Europe follows closely, propelled by coordinated national research strategies and strong public funding. Germany's UNITE Glioblastoma project, supported by the German Research Foundation's Collaborative Research Centers, exemplifies the region's growing commitment to tackling glioblastoma multiforme through advanced research and cross-border collaboration. The Asia-Pacific region is witnessing rapid progress, with governments, academia, and private stakeholders stepping up investment. Japan's conditional approval of DELYTACT (G47∆) the world's first oncolytic virus therapy for malignant gliomas, highlights the region's increasing role in therapeutic innovation. Meanwhile, the Middle East and Africa are in the early stages of glioblastoma multiforme research development. Though challenged by limited infrastructure and funding, emerging efforts from academic centers and private healthcare providers are laying the groundwork for future growth and capacity-building. As glioblastoma multiforme remains one of the most aggressive brain cancers, regional efforts will continue to shape the global response, advancing innovation, access, and treatment outcomes. Recent Advancements and Key Players in the Glioblastoma Therapeutics Market Several prominent players, including Novocure, Roche, Merck & Co., Novartis, Daiichi Sankyo, Allergan, Laminar Pharmaceuticals, Vigeo Therapeutics, Eli Lilly, Incyte Corporation, Kazia Therapeutics, and TVAX Biomedical, are advancing innovation in the glioblastoma treatment landscape. These companies are focused on developing novel therapeutics, targeted drug delivery systems, and strategic collaborations to tackle one of the most aggressive forms of brain cancer. In March 2025, Laminar Pharmaceuticals announced promising results from its ongoing Phase 2b/3 clinical trial (NCT04250922) of LAM561 in newly diagnosed glioblastoma (ndGBM). The randomized, double-blind, placebo-controlled study evaluates LAM561 in combination with standard chemoradiotherapy (radiotherapy and temozolomide). Early data revealed a positive trend in progression-free survival (PFS), particularly in patients with MGMT-methylated tumors. The trial is partially supported by the EU H2020 ClinGlio initiative, reinforcing the importance of public-private partnerships in advancing brain cancer research. Similarly, on June 2, 2025, Sapience Therapeutics presented updated clinical and biomarker data from its ongoing Phase 2 trial of Lucicebtide (formerly ST101) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Lucicebtide, a first-in-class C/EBPβ antagonist, demonstrated encouraging results in glioblastoma patients, further validating its mechanism of action and potential as a novel targeted therapy. Further driving progress, on April 1, 2025, Spanios and GlioGuard announced a strategic partnership to accelerate glioblastoma drug discovery and development. This collaboration aims to deliver more effective and personalized treatment options for glioblastoma multiforme, addressing the urgent need for breakthroughs in one of the most treatment-resistant forms of cancer. These advancements highlight the growing momentum in glioblastoma therapeutics. With continued innovation, clinical progress, and collaborative efforts, the industry is poised to improve patient outcomes and reshape the future of brain cancer treatment. Book a 1:1 Presentation to Discuss Key Trends and Strategic Takeaways: Future Outlook: Evolving the Glioblastoma Multiforme Treatment Landscape The glioblastoma multiforme treatment market is under transformation. By 2030, a combination of drug innovation, device advancement, and integrated care models is expected to redefine survival outcomes for this aggressive brain cancer. Oral therapies currently lead the market, driven by ease of use and improved patient adherence. Injectables follow, offering systemic options like chemotherapies and targeted biologics. Implants, such as localized wafers, remain a niche but vital component post-surgery. Therapies, especially multi-modal regimens, dominate the market and are expanding rapidly, as combination approaches become the clinical standard. The next wave will be led by immunotherapies and immune checkpoint inhibitors, poised to break the disease immune resistance. These emerging treatments will increasingly complement traditional modalities, aiming for longer progression-free and overall survival. Wearable devices, particularly Novocure's Optune Gio, represent a paradigm shift. Future versions will be lighter, more personalized, and AI-integrated, enabling real-time therapy adjustments and remote monitoring, bringing glioblastoma multiforme care closer to the patient. Key Competitors Novocure Roche Merck & Co. Novartis Daiichi Sankyo Allegran Laminar pharmaceuticals Vigeo therapeutics Eli lily Incyte corporation Kazia Therapuetics TVAX Biomedicals Segmentation: Glioblastoma Multiforme Treatment Market By Treatment Type Surgery (Gliadel wafer) Therapies Chemotherapy Temzolomide Lomustine Radiation Therapy Targeted Therapy (Bevacizumab) Others (Delytact) Tumor Treating Fields (TTF) (Optune Gio) By Dosage Form Oral Injectables Implant and TFF Field Device By End Users Hospitals & Clinics (specialty clinics) Cancer Treatment Centers Academic and Research Organizations By Region North America South America Europe Asia Pacific Middle East and Africa Still Have Questions? Contact Us for Clarification or a Custom Data Request: About Astute Analytica Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements. With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace. Contact Us:Astute AnalyticaPhone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)For Sales Enquiries: sales@ Follow us on: LinkedIn | Twitter | YouTube CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@ Website: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
01-07-2025
- Business
- Business Wire
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
BAAR, Switzerland--(BUSINESS WIRE)--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 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 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. ii International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. v International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. vi American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025
Business Wire
30-06-2025
- Business
- Business Wire
Novocure to Report Second Quarter 2025 Financial Results
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) will report financial results for the second quarter 2025 on July 24, 2025, before the U.S. financial markets open. Novocure management will host a conference call and webcast at 8:00 a.m. EDT, July 24, to discuss the company's financial results for the three- and six-month periods that ended June 30, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure's website, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. 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 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 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 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.
Yahoo
02-06-2025
- Business
- Yahoo
NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial
Zai Lab Limited (NASDAQ:ZLAB) and NovoCure Limited (NASDAQ:NVCR) revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer. The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting. The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints, including one-year and pain-free survival rates. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group, 68.1%, compared to 60.2% for those who received gemcitabine and nab-paclitaxel alone. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months compared to a median of 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until patients reported an increase of 20 or more points on a visual scale for pain or until death. There was no statistically 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 TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Price Action: NVCR stock is trading lower by 8.63% to $17.46 at last check Monday. Read Next:Photo by Aunt Spray via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
