Tumor Treating Fields is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with … March 22, 2019. 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. The PANOVA-3 trial (also known as the “EF-27 trial”) is a pivotal (analogous to a drug Phase III), randomized controlled trial, designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L(P) System [About TTFields] in combination with gemcitabine and nab-paclitaxel as front-line treatment for patients with … Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers. acordova@novocure.com Patient images reflect the health status of the patients at the time each photo or video was taken. Looking forward, with more patients being enrolled in phase 3 trials for other tumor types. 3. 2. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. Patient images reflect the health status of the patients at the time each photo or video was taken. Please click here to access it. Ovarian cancer is the fifth leading cause of cancer death among women. https://www.businesswire.com/news/home/20190322005019/en/, Novocure Vulnerability Disclosure Process. “We have a clear, unmet need for an effective treatment for brain metastasis, a … For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. Stupp R, Taillibert S, Kanner A, et al. “Ovarian cancer is one of the most aggressive forms of cancer,” said Professor Ignace Vergote, Chairman of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union. 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 combination with immune checkpoint inhibitors or docetaxel – a taxane chemotherapy – two of the current standard of care treatments. Novocure’s commercialized product is approved for the treatment of adult patients with glioblastoma. “INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial beyond glioblastoma, demonstrating our commitment to developing Tumor Treating Fields for a variety of solid tumors,” said Asaf Danziger, Novocure’s Chief Executive Officer. INNOVATE-3 is Novocures fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. Novocure has ongoing phase 3 pivotal trials in brain metastases from NSCLC and in advanced NSCLC after failing platinum-based therapy. We have revised our Privacy Policy that is in effect as of May 25, 2018. ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that it has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. The Private Securities Litigation Reform Act of 1995 permits this discussion. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. 212-767-7558. 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. INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. 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. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. METIS is Novocure’s first phase 3 … Therefore, you should not rely on any such factors or forward-looking statements. In addition, the trial will test non-inferiority in overall survival of patients treated with TTFields plus docetaxel versus immune checkpoint inhibitors alone. Novocure has grown significantly in the past several years. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of NSCLC by the U.S. Food and Drug Administration. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support including brain, lung, and ovarian, the scope of Novocure… Ovarian cancer is one of the most … Lung cancer is the leading cause of cancer-related death in the United States. By continuing to browse the site you are agreeing to accept our use of cookies. “We believe that treatment with TTFields is bigger than one cancer type. Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. ... A phase III study of TTFields combined with chemotherapy for advanced 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. We are now a global company with more than 450 employees, two FDA approvals and a robust clinical pipeline. 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.”. Optune Instructions For Use. Novocure developed the trial design for INNOVATE-3 after learning the results of its phase 2 pilot trial of Tumor Treating Fields in combination with weekly paclitaxel, the INNOVATE trial. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly diagnosed glioblastoma (GBM) testing the potential survival benefit of initiating Optune concurrent with radiation therapy. Novocure 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. “Ovarian cancer is one of the most aggressive forms of cancer,” said Professor Ignace Vergote, Chairman of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. 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. Tumor Treating Fields is approved for the treatment of adults with GBM. 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 submission and 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. The international trial is planned to include 512 patients with stage IIIB and IV NSCLC of all histologies after failing platinum-based therapy. The primary endpoint is overall survival. Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. “Ovarian cancer is one of the most aggressive forms of cancer,” said 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 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 … This was driven by an increase in expenses for Novocure's phase 3 pivotal and post-marketing trials, as well as expenses to support product development programs, and investments in … 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. Professor Yoram Palti founded Novocure in 2000. INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer, Ovarian cancer is the fifth leading cause of cancer death among women. “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 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. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. In 31 evaluable patients, the INNOVATE trial suggested a more than doubling of progression free survival and an improvement in overall survival among patients who received Optune with paclitaxel compared to paclitaxel alone. When I first started, I was one of six Device Support Specialists hired in the U.S. to support clinical patients in the company’s first phase 3 pivotal study. INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer ... | January 22, 2021 In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Any forward-looking statements herein speak only as of the date hereof. The incidence of ovarian cancer is approximately 22,500 new cases annually in the United States, approximately 68,000 new cases annually in Europe, and approximately 10,000 new cases annually in Japan. An oral presentation will focus on how compliance and treatment duration may predict survival in newly diagnosed glioblastoma patients treated with Optune® together with... | January 23, 2021 In the United States, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Based on these results, Novocure plans to start a phase 3 trial in recurrent ovarian cancer in 2018. Any forward-looking statements herein speak only as of the date hereof. ST. HELIER, N.J., Oct. 12, 2016 (GLOBE NEWSWIRE) — Novocure (NASDAQ:NVCR) announced today that the first patient has been enrolled in the METIS trial, a phase 3 pivotal trial studying radiosurgery plus Tumor Treating Fields (TTFields) compared to radiosurgery alone for the treatment of brain metastases from non-small cell lung cancer (NSCLC).). On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. Novocure developed the trial design for INNOVATE-3 after learning the results of its phase 2 pilot trial of Tumor Treating Fields in combination with weekly paclitaxel, the INNOVATE trial. 2017;318(23):2306­-2316. ST. 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 February 28, 2019, with the U.S. Securities and Exchange Commission. Novocure developed the trial design for INNOVATE-3 afterlearning the results of its phase 2 pilot trial of Tumor Treating Fields incombination with weekly paclitaxel, the INNOVATE trial. Professor Yoram Palti founded Novocure in 2000. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. Novocure has enrolled the first patient in Phase 3 TRIDENT trial, evaluating Optune, a non-invasive, antimitotic cancer treatment, used concurrent with radiation therapy in newly diagnosed glioblastoma (GBM). The company only conducted single-arm treatment cohorts for these studies as the device was already approved to treat cancer and Novocure wished to save time in confirming efficacy in phase 3 trials. Novocure (NASDAQ: NVCR) announced today that it has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. Novocure 2016. The EF-15 study showed that TTFields are safe and tolerable in patients with advanced NSCLC. This website intends to use cookies to improve the site and your experience. Ashley Cordova Stupp R, Taillibert S, Kanner A, et al. “Most ovarian cancer patients are diagnosed at an advanced stage, which makes the disease difficult to treat. http://www.businesswire.com/news/home/20170215005187/en/, Novocure Vulnerability Disclosure Process. Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance. By continuing to browse the site you are agreeing to accept our use of cookies. ST. HELIER, N.J., Oct. 12, 2016 -- Novocure (NASDAQ:NVCR) announced today that the first patient has been enrolled in the METIS trial, a phase 3 … 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. In 2014, Novocure faced unanswered questions from the scientific, medical and investment communities regarding the potential of its innovative therapy. 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. Toggle navigation. Novocure announces the EF-14 phase 3 pivotal clinical trial stopped for early success at interim analysis. INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. In 2019, Novocure partnered with the European Network for Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation, Inc. to run its phase 3 pivotal trial in ovarian cancer, INNOVATE-3. 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 safety and effectiveness of Tumor Treating Fields for ovarian cancer has not been established. INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. Ovarian cancer has been an important area of focus for our research because of the great unmet need faced by these patients. Professor Vergote said he plans to participate. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. Novocure is developing TTFields for different cancer diseases, such as: pancreatic cancer, ovarian cancer, lung cancer, mesothelioma and brain metastasis. 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. 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. The safety and effectiveness of TTFields therapy for NSCLC has not been established. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. We are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible.”. The science of Tumor Treating Fields extends beyond glioblastoma. 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. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. The science of Tumor Treating Fields extends beyond glioblastoma. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. We are pleased to begin this trial that has the potential to improve survival in recurrent ovarian cancer.”. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. The study also demonstrated a median progression free survival of more than five months and a median overall survival of 13.8 months. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. 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. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. METIS is Novocure’s first phase 3 pivotal trial outside of glioblastoma. JAMA. 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. INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer. Novocure (NASDAQ: NVCR) today announced the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly … 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. The Private Securities Litigation Reform Act of 1995 permits this discussion. 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. This website intends to use cookies to improve the site and your experience. In 2019, Novocure collaborated with Zai Lab to begin a phase 2 pilot trial of Tumor Treating Fields in gastric cancer in Greater China. View source version on businesswire.com: https://www.businesswire.com/news/home/20190322005019/en/, Media and Investor Contact: “I’ve always been very interested in innovation and trying to find new treatment modalities to help our patients,” he said. “We are excited about the potential of TTFields for the treatment of advanced NSCLC, and we are pleased to start this pivotal trial.”. 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. For more information on the trial design, visit ClinicalTrials.gov. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Lung Cancer. Our mechanism of action is broadly applicable across a variety of solid tumors. Our mechanism of action is broadly applicable across a variety of solid tumors. Current treatment options are not enough for these patients. INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. (Credit: Novocure.) We have since accomplished many significant milestones. Novocure (NASDAQ: NVCR) announced today that it has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. The incidence of NSCLC in the U.S. is approximately 185,000 new cases annually. including brain, lung, and ovarian, the scope of Novocure… Novocure has ongoing phase 3 pivotal trials in brain metastases from NSCLC and in advanced NSCLC after failing platinum-based therapy. “At Novocure, we strive to extend survival in some of the most aggressive forms of cancer. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. 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. 10.12.2020 - Novocure (NASDAQ: NVCR) today announced the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in … We have revised our Privacy Policy that is in effect as of May 25, 2018. Patients will be randomized to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating Fields tuned to 200 kHz until progression. Please click here to access it. Looking forward, with more patients being enrolled in phase 3 trials for other tumor types. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support These results exceeded historical results for second-line treatment of advanced NSCLC with pemetrexed chemotherapy alone. We have since accomplished many significant milestones. 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. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Nsclc after failing platinum-based therapy from the scientific, medical and investment communities novocure phase 3 the potential of innovative! S current expectations or forecasts of future events median age at time of diagnosis is years... 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