-- Analyses of PRiDe, a registry of 457 recurrent glioblastoma patients, show that patients treated with the NovoTTF™-100A System at their first and second recurrences had median overall survivals of 20.0 and 8.5 months, respectively
ST. HELIER, Jersey, Sept. 25, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today that survival and efficacy data from its U.S. patient registry will be presented at the European Society for Medical Oncology (ESMO) Meeting in Madrid, Spain, September 26-30, 2014 and at the European Association of Neuro-Oncology (EANO) Meeting in Turin, Italy, October 9-12, 2014. In addition to the clinical data presentations, Novocure will be hosting a Satellite Symposium on NovoTTF therapy at the EANO meeting on October 11, 2014.
The U.S. patient registry dataset or PRiDe includes data from every recurrent glioblastoma patient treated with the NovoTTF-100A System from October 2011 through November 2013 at 91 leading oncology centers in the United States (n=457). Analyses of the PRiDe data showed that recurrent glioblastoma patients treated with the NovoTTF-100A System in the real-world setting at first or second recurrence had a longer median overall survival (OS) compared to patients treated at their third or subsequent recurrence (median OS of 20.0 months and 8.5 months, respectively, compared to 4.9 months, p<0.0001). Another PRiDe analysis showed that the median OS of bevacizumab-naive recurrent glioblastoma patients treated with the NovoTTF-100A System was significantly longer than the median OS of recurrent glioblastoma patients treated with bevacizumab prior to treatment with the device (median OS 13.4 months vs. 7.2 months, p=0.0001).
Details of the ESMO and EANO clinical data presentations and the satellite symposium are listed below and can be found online at www.esmo.org and www.eano.eu.
ESMO 2014 Congress - Madrid, Spain
Date: Saturday, September 27, 2014Venue/Time: Salamanca/ 14:00-15:45 CETType: Oral Presentation
Abstract 4150: Alternating Electric Fields Therapy for Recurrent Glioblastoma - NovoTTF-100A System: Updated Outcomes and Toxicity Based on the Analysis of Patient Registry DataPresenter: Maciej M. Mrugala MD, PhD, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA
EANO 2014 Meeting - Turin, Italy
Date: Saturday, October 11, 2014Venue/Time: Poster Session/ 17:00-18:00 CETType: Poster Presentation
Abstract 233: NovoTTF-100A Alternating Electric Fields Therapy for Recurrent Glioblastoma - Analysis of Patient Registry Data Presenter: Eric T. Wong MD, Beth Israel Deaconess Medical Center, Boston, MA
NovoTTF Therapy for Glioblastoma: Learnings from 14 Years of Development and Clinical ResearchDate: Saturday, October 11, 2014Venue/Time: Room 500/ 18:00-19:00 CETType: Satellite Symposium Chair: Riccardo Soffietti MD, Universita' degli Studi di Torino, Torino, IT
About Glioblastoma Glioblastoma (GBM) is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the United States. The disease is known as recurrent glioblastoma when the tumor progresses or recurs after initial treatment. Overall survival from the time of recurrence has been reported at 3-5 months without active treatment.
About the NovoTTF-100A System NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that the NovoTTF-100A System slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A System creates a low intensity, alternating electric field within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death. In patients with recurrent glioblastoma brain tumors, the system has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy. The NovoTTF-100A System has received marketing approval in the United States (U.S.) and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.
Approved Indication The FDA has approved the NovoTTF-100A System for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM, following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The system is intended to be used as monotherapy and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the system. Full prescribing information is available at www.novottftherapy.com or by calling toll free 1-855-281-9301.
About Novocure™ Novocure is a global oncology business with subsidiaries in the U.S., Europe, and Asia. Novocure's mission is to improve the lives of cancer patients through the development and commercialization of NovoTTF Therapy as a fourth modality in cancer care. Novocure's U.S. operations are based in Portsmouth, NH and New York, NY with European operations based in Luzerne, Switzerland and Asian operations based in Toyko, Japan. The company's research center is in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Media Contact: Peter Melnyk, Novocurepmelnyk@novocure.com+1-212-767-7534
Investor Contact: Ashley Cordova, Novocureacordova@novocure.com+1-212-767-7558
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