The prospective, randomized, controlled trial will test the efficacy and safety of TTFields in combination with immune checkpoint inhibitors or docetaxel – a taxane chemotherapy – two of the current standard of care treatments. We completed phase 2 pilot trials in pancreatic cancer and ovarian cancer, and shared the topline results at our research and development day in … By their nature, forward-looking statements involve risk and uncertainty, and Novocure's performance and … Patient images reflect the health status of the patients at the time each photo or video was taken. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. ... Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021) Novocure, the trial sponsor, maintains this website to help patients get basic information about this clinical trial and facilitate their accessibility to medical centers that offer participation in this trial [ LUNAR Centers ]. We are developing a profoundly different approach to cancer therapy that has the potential to improve the lives of people affected by a range of solid tumor cancers.”. During her seventeen years with Novocure, she and the preclinical team have researched the effects of TTFields on a variety of solid tumor cancer cell lines and laid the foundation for Novocure’s expansion into additional clinical trials. The LUNAR trial design was based on preclinical findings that suggest TTFields may act synergistically with certain taxanes and enhance the efficacy of immune checkpoint inhibitors. Full year 2020 preliminary net revenues of $494.4 million, representing annual growth of 41 percent compared to 2019. Novocure is developing TTFields for different cancer diseases, such as: pancreatic cancer, ovarian cancer, lung cancer, mesothelioma and brain metastasis. If you require further information and/or do not wish to have cookies placed when using the site, review the Cookies section of our Website Privacy Policy or visit www.allaboutcookies.org. At 10%-30% peak market penetration, 0.5 billion to 1.5 billion can be added to NovoCure revenue. The data suggested that Tumor Treating Fields in combination with weekly paclitaxel is tolerable and safe. “We believe that treatment with TTFields is bigger than one cancer type. Novocure LUNAR Description LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) announced today that the first patient has been enrolled in LUNAR, its phase 3 pivotal trial of Tumor Treating Fields at 150 kHz as a treatment for advanced non-small cell lung cancer (NSCLC) after failing platinum-based therapy.The prospective, randomized, controlled trial will test the efficacy and safety of TTFields in … It also plans to issue an interim analysis of a phase three pivotal PANOVA-3 trial in locally advanced pancreatic cancer as well as an interim analysis of a phase three pivotal INNOVATE-3 trial in recurrent ovarian cancer. Novocure also plans to highlight key clinical and product development … For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. “The start of LUNAR, our second ongoing phase 3 trial beyond glioblastoma, further demonstrates our commitment to testing TTFields across a variety of solid tumor cancers and bringing our therapy to patients who may benefit from it,” said Novocure CEO Asaf Danziger. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. Any forward-looking statements herein speak only as of the date hereof. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, with the U.S. Securities and Exchange Commission. Novocure reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2020. Novocure in light of industry experience and perception of historical trends, current conditions, expected future developments and other appropriate factors. In addition, the trial will test non-inferiority in overall survival of patients treated with TTFields plus docetaxel versus immune checkpoint inhibitors alone. ST. HELIER, Jersey– (BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the first patient has been enrolled in LUNAR, its phase 3 pivotal trial of Tumor Treating Fields at 150 kHz as a treatment for advanced non-small cell … The incidence of NSCLC in the U.S. is approximately 185,000 new cases annually. For more information on the trial design, visit ClinicalTrials.gov. The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields … 2013 Jul 23. pii: S0169-5002(13)00308-5. doi: 10.1016, View source version on businesswire.com: http://www.businesswire.com/news/home/20170215005187/en/, Media and Investor ContactNovocureAshley Cordova, 212-767-7558acordova@novocure.com. The safety and effectiveness of TTFields therapy for NSCLC has not been established. We have since accomplished many significant milestones. The LUNAR trial is intended for patients who have recently been diagnosed with progression of non-small cell lung cancer (NSCLC) during or after platinum based therapy. Novocure continues to test Tumor Treating Fields against a broad range of solid tumor types. Novocure today reported fourth quarter and full year 2019 financial results and provided a company update. “We designed this trial to test TTFields with two of the currently available standard of care treatments for advanced NSCLC following failure of platinum-based therapy, opening the trial to more patients with this disease,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. The trial will test the efficacy and safety of TTFields at 150 kHz in combination with two of the current standard of care treatments, immune checkpoint inhibitors or docetaxel ... | October 16, 2020 In February 2017, we enrolled the first patient in our phase 3 pivotal LUNAR trial studying TTFields in patients with advanced non-small cell lung cancer. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. http://www.businesswire.com/news/home/20170215005187/en/, Novocure Vulnerability Disclosure Process. Professor Yoram Palti founded Novocure in 2000. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Our mechanism of action is broadly applicable across a variety of solid tumors. Lung Cancer. Roza Shnayderman, Head of Novocure’s Israel Biology Lab, joined Novocure in March 2000. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure is a commercial-stage oncology company developing a proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. This clinical trial is evaluating the safety and efficacy of the NovoTTF-100L System for use in NSCLC, when added to either an immune checkpoint inhibitor or docetaxel which are normally given to patients in this condition. “We are excited about the potential of TTFields for the treatment of advanced NSCLC, and we are pleased to start this pivotal trial.”. On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. Fourth quarter and full year 2020 financial results to be reported Thursday, Feb. 25, 2021 Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer More Information. Data from phase 3 METIS trial and from phase 2 pilot EF-33 trial in 2022. Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2023) ... Novocure will host a conference call and webcast to discuss fourth quarter and … Final data from phase 3 pivotal LUNAR trial … Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, … Specifically, it was being explored in patients who progressed during or … If you would like to take part in the LUNAR trial, please contact one of the participating centers as soon as possible. Novocure reported financial results for the quarter ended June 30, 2020, and provided a company update. Please click here to access it. Novocure is due to issue an interim analysis of a phase three pivotal LUNAR trial in non-small-cell lung cancer. Novocure to present at the 39 th Annual J.P. Morgan Virtual Healthcare Conference at 8:20 a.m. EST on Tuesday, Jan. 12, 2021. Company Participants. NovoCure Ltd. ClinicalTrials.gov Identifier: NCT03780569 Other Study ID Numbers: ICH-1 : First Posted: December 19, 2018 Key Record Dates: Last Update Posted: December 20, 2018 Last Verified: December 2018 Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022) Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2020.Novocure plans to discuss these results with investors at the 39 th Annual J.P. Morgan Virtual Healthcare Conference. NovoCure is also anticipating interim data from some Phase III trials. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. 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. For more information on our ongoing clinical trials, visit novocuretrial.com and clinicaltrials.gov. If you would like to take part in the LUNAR trial, please contact one of the participating centers as soon as possible. If you have questions concerning your medical condition and recommended treatment, please consult with your treating doctor. We have revised our Privacy Policy that is in effect as of May 25, 2018. The Private Securities Litigation Reform Act of 1995 permits this discussion. Lung cancer is the leading cause of cancer-related death in the United States. The science of Tumor Treating Fields extends beyond glioblastoma. LUNAR is a pivotal, phase III trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L System in … NovoCure Limited (NASDAQ:NVCR) Q2 2020 Results Conference Call July 30, 2020 8:00 AM ET. By continuing to browse the site you are agreeing to accept our use of cookies. The trial will test the efficacy and safety of TTFields at 150 kHz in combination with two of the current standard of care treatments, immune checkpoint inhibitors or docetaxel. Ashley Cordova - Senior Vice … This website intends to use cookies to improve the site and your experience. NovoCure (NASDAQ:NVCR) Q2 ... tumor treating fields and anti-PD-1 therapies as a second-line treatment for stage IV non-small cell lung cancer in our Lunar trial… The international trial is planned to include 512 patients with stage IIIB and IV NSCLC of all histologies after failing platinum-based therapy. 1 Pless M. et al., A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. These results exceeded historical results for second-line treatment of advanced NSCLC with pemetrexed chemotherapy alone. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, … Notably, the EF-15 trial also included patients with squamous histology (n=7, 17 percent), who typically do not respond to treatment with pemetrexed. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. We sponsor clinical trials of Tumor Treating Fields in several cancer types. Final data from phase 3 LUNAR trial in NSCLC, from phase 3 PANOVA-3 trial … The NovoTTF-100L System delivers Tumor Treating Fields (TTFields) to the cancer in the chest. Novocure’s INNOVATE trial examined Tumor Treating Fields in combination with standard of care chemotherapy in patients with recurrent platinum-resistant ovarian cancer. Novocure has ongoing phase 3 pivotal trials in brain metastases from NSCLC and in advanced NSCLC after failing platinum-based therapy. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of NSCLC by the U.S. Food and Drug Administration. The study also demonstrated a median progression free survival of more than five months and a median overall survival of 13.8 months. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, … ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the first patient has been enrolled in LUNAR, its phase 3 pivotal trial of Tumor Treating Fields at 150 kHz as a treatment for advanced non-small cell lung cancer (NSCLC) after failing platinum-based therapy. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, … Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers. The EF-15 study showed that TTFields are safe and tolerable in patients with advanced NSCLC. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. Broad applicability of the mechanism of action. In addition, the trial design was informed by Novocure’s phase 2 pilot EF-15 trial1, which tested TTFields at 150 kHz in combination with pemetrexed chemotherapy in 42 patients with advanced second- or subsequent-line NSCLC. Following the study, Novocure announced that it was testing the combination of Tumor Treating Fields with immune checkpoint inhibitors in its Phase III LUNAR trial in patients with stage 4 NSCLC. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. 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