Dec.22

novocure phase 3

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 has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer ... | January 22, 2021 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. (Credit: Novocure.) Professor Yoram Palti founded Novocure in 2000. 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. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. The incidence of NSCLC in the U.S. is approximately 185,000 new cases annually. 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. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma. Ashley Cordova 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).). Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. 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. Tumor Treating Fields is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. 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. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Novocure is a commercial-stage oncology company developing a proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. This website intends to use cookies to improve the site and your experience. Novocure has grown significantly in the past several years. The international trial is planned to include 512 patients with stage IIIB and IV NSCLC of all histologies after failing platinum-based therapy. Lung Cancer. 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 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. 212-767-7558. 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 Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with … The EF-15 study showed that TTFields are safe and tolerable in patients with advanced NSCLC. The safety and effectiveness of Tumor Treating Fields for ovarian cancer has not been established. 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 … 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. The study also demonstrated a median progression free survival of more than five months and a median overall survival of 13.8 months. including brain, lung, and ovarian, the scope of Novocure… Notably, the EF-15 trial also included patients with squamous histology (n=7, 17 percent), who typically do not respond to treatment with pemetrexed. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. 3. 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. Current treatment options are not enough for these patients. “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. 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 … 2. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. 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. “I’ve always been very interested in innovation and trying to find new treatment modalities to help our patients,” he said. 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. acordova@novocure.com The primary endpoint is overall survival. Ovarian cancer is one of the most … INNOVATE-3 is Novocures fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. 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. “We have a clear, unmet need for an effective treatment for brain metastasis, a … INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma. Stupp R, Taillibert S, Kanner A, et al. 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. 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 Novocure (NASDAQ: NVCR) today announced the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly … Professor Vergote said he plans to participate. By continuing to browse the site you are agreeing to accept our use of cookies. 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. Ovarian cancer has been an important area of focus for our research because of the great unmet need faced by these patients. 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. We have since accomplished many significant milestones. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Ovarian cancer is the fifth leading cause of cancer death among women. Optune Instructions For Use. “We are excited about the potential of TTFields for the treatment of advanced NSCLC, and we are pleased to start this pivotal trial.”. Therefore, you should not rely on any such factors or forward-looking statements. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. 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. Any forward-looking statements herein speak only as of the date hereof. METIS is Novocure’s first phase 3 … 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. March 22, 2019. “Most ovarian cancer patients are diagnosed at an advanced stage, which makes the disease difficult to treat. 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. Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance. For more information on the trial design, visit ClinicalTrials.gov. Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer. View source version on businesswire.com: https://www.businesswire.com/news/home/20190322005019/en/, Media and Investor Contact: 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. 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. By continuing to browse the site you are agreeing to accept our use of cookies. 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 2016. Please click here to access it. 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 science of Tumor Treating Fields extends beyond glioblastoma. We have revised our Privacy Policy that is in effect as of May 25, 2018. 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.”. METIS is Novocure’s first phase 3 pivotal trial outside of glioblastoma. Please click here to access it. JAMA. INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. 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. “Ovarian cancer is one of the most aggressive forms of cancer,” said 2017;318(23):2306­-2316. Patient images reflect the health status of the patients at the time each photo or video was taken. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. ST. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. 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