$NVCN Blog Exposure - NovoCure Announced Positive Top-line Results from STELLAR Trial Assessing TTFields in Mesothelioma
LONDON, UK / ACCESSWIRE / April 19, 2018 / Active-Investors.com has just released a free research report on NovoCure Ltd (NASDAQ: NVCR). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=NVCR as the Company's latest news hit the wire. On April 17, 2018, the Company announced positive top-line results from its phase-2 pilot trial, STELLAR, evaluating Tumor Treating Fields (TTFields) plus standard of care chemotherapy, pemetrexed and cisplatin or carboplatin, in patients with mesothelioma, compared to historical control data of patients who received standard of care chemotherapy alone. The data demonstrated clinically meaningful improvements in overall survival (OS) and progression free survival (PFS). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is currently working on the research report for Neovasc Inc. (NASDAQ: NVCN), which also belongs to the Healthcare sector as the Company NovoCure. Do not miss out and become a member today for free to access this upcoming report at:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, NovoCure most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
www.active-investors.com/registration-sg/?symbol=NVCR
Final Data of STELLAR Phase-2 Trial Exceeded the Results of Interim Analysis
The STELLAR trial is a phase-2 pilot single-arm, open-label, multi-center trial designed to test the efficacy and safety of TTFields in combination with standard of care chemotherapy, pemetrexed combined with cisplatin or carboplatin, in 80 patients with unresectable, previously untreated malignant pleural mesothelioma. An interim analysis of the first 42 patients enrolled in the trial with an average follow-up time of 11.5 months was presented at the International Association for the Study of Lung Cancer (IASLC) in December 2016. The one-year survival rate of patients treated with TTFields combined with pemetrexed and cisplatin or carboplatin was 80%. Median PFS in the TTFields-treated group was 7.3 months and one-year survival rate was 79.7%.
The final data exceeded the results of the interim analysis for all efficacy endpoints. No device-related serious adverse events were reported. NovoCure will submit the full data for presentation at an upcoming medical conference.
Mesothelioma is the First Torso Indication for which NovoCure Will Pursue FDA Approval
Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at NovoCure, stated that the Company is extremely pleased with these top-line results, which brings it one step closer to realizing the potential for a new treatment for mesothelioma patients in desperate need. According to him, Mesothelioma is the first torso indication for which NovoCure will pursue FDA approval.
Dr. Eilon added that the STELLAR data reinforce NovoCure's belief that TTFields may be a broadly applicable platform technology for the treatment of solid tumors.
NovoCure Plans to Submit a Humanitarian Device Exemption Application to the FDA
In May 2017, NovoCure received Humanitarian Use Device (HUD) designation for the use of TTFields for the treatment of pleural mesothelioma. Based upon the final STELLAR data, the Company plans to submit a Humanitarian Device Exemption (HDE) application to the FDA for approval. An approved HDE would allow NovoCure to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.
About Mesothelioma
Mesothelioma is a rare, aggressive form of cancer that develops in the lining of the lungs, abdomen, or heart. Caused by asbestos, mesothelioma has no known cure and has a very poor prognosis. According to a 2017 report by the Centers for Disease Control, 2,400-2,800 people are diagnosed with mesothelioma in the United States each year.
About NovoCure Ltd
Founded in 2000 and headquartered in Saint Helier, Jersey, NovoCure is a commercial-stage oncology company developing a novel, proprietary therapy called TTFields, for the treatment of solid tumor cancers. NovoCure's commercialized product is approved for the treatment of adult patients with glioblastoma.
LONDON, UK / ACCESSWIRE / April 19, 2018 / Active-Investors.com has just released a free research report on NovoCure Ltd (NASDAQ: NVCR). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=NVCR as the Company's latest news hit the wire. On April 17, 2018, the Company announced positive top-line results from its phase-2 pilot trial, STELLAR, evaluating Tumor Treating Fields (TTFields) plus standard of care chemotherapy, pemetrexed and cisplatin or carboplatin, in patients with mesothelioma, compared to historical control data of patients who received standard of care chemotherapy alone. The data demonstrated clinically meaningful improvements in overall survival (OS) and progression free survival (PFS). Register today and get access to over 1,000 Free Research Reports by joining our site below:
www.active-investors.com/registration-sg
Active-Investors.com is currently working on the research report for Neovasc Inc. (NASDAQ: NVCN), which also belongs to the Healthcare sector as the Company NovoCure. Do not miss out and become a member today for free to access this upcoming report at:
www.active-investors.com/registration-sg/?symbol=NVCN
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, NovoCure most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
www.active-investors.com/registration-sg/?symbol=NVCR
Final Data of STELLAR Phase-2 Trial Exceeded the Results of Interim Analysis
The STELLAR trial is a phase-2 pilot single-arm, open-label, multi-center trial designed to test the efficacy and safety of TTFields in combination with standard of care chemotherapy, pemetrexed combined with cisplatin or carboplatin, in 80 patients with unresectable, previously untreated malignant pleural mesothelioma. An interim analysis of the first 42 patients enrolled in the trial with an average follow-up time of 11.5 months was presented at the International Association for the Study of Lung Cancer (IASLC) in December 2016. The one-year survival rate of patients treated with TTFields combined with pemetrexed and cisplatin or carboplatin was 80%. Median PFS in the TTFields-treated group was 7.3 months and one-year survival rate was 79.7%.
The final data exceeded the results of the interim analysis for all efficacy endpoints. No device-related serious adverse events were reported. NovoCure will submit the full data for presentation at an upcoming medical conference.
Mesothelioma is the First Torso Indication for which NovoCure Will Pursue FDA Approval
Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at NovoCure, stated that the Company is extremely pleased with these top-line results, which brings it one step closer to realizing the potential for a new treatment for mesothelioma patients in desperate need. According to him, Mesothelioma is the first torso indication for which NovoCure will pursue FDA approval.
Dr. Eilon added that the STELLAR data reinforce NovoCure's belief that TTFields may be a broadly applicable platform technology for the treatment of solid tumors.
NovoCure Plans to Submit a Humanitarian Device Exemption Application to the FDA
In May 2017, NovoCure received Humanitarian Use Device (HUD) designation for the use of TTFields for the treatment of pleural mesothelioma. Based upon the final STELLAR data, the Company plans to submit a Humanitarian Device Exemption (HDE) application to the FDA for approval. An approved HDE would allow NovoCure to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.
About Mesothelioma
Mesothelioma is a rare, aggressive form of cancer that develops in the lining of the lungs, abdomen, or heart. Caused by asbestos, mesothelioma has no known cure and has a very poor prognosis. According to a 2017 report by the Centers for Disease Control, 2,400-2,800 people are diagnosed with mesothelioma in the United States each year.
About NovoCure Ltd
Founded in 2000 and headquartered in Saint Helier, Jersey, NovoCure is a commercial-stage oncology company developing a novel, proprietary therapy called TTFields, for the treatment of solid tumor cancers. NovoCure's commercialized product is approved for the treatment of adult patients with glioblastoma.
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