-- The supplement is intended to provide an overview of available knowledge regarding the use of NovoTTF Therapy for the treatment of recurrent glioblastoma, as well as its development for the treatment of lung cancer
-- Analyses of PRiDe, a registry of 457 recurrent glioblastoma patients, demonstrate 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, Oct. 29, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today the publication of four articles on NovoTTF Therapy in a Seminars in Oncology supplement.
The supplement includes an article describing the findings from Novocure's U.S. commercial Patient Registry Dataset (PRiDe) and 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 recurrences (median OS of 20.0 months and 8.5 months compared to 4.9 months, respectively, p<0.0001). Another PRiDe analysis showed that the median overall survival 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 NovoTTF-100A System (median OS 13.4 months vs. 7.2 months, respectively, p=0.0001).
"The PRiDe analyses, together with clinical data previously reported, indicate that NovoTTF Therapy offers true clinical benefit to patients with recurrent GBM," said Maciej Mrugala, M.D., Associate Professor of Neurology and Neurological Surgery at the University of Washington. "Additionally, NovoTTF Therapy is well tolerated and has a favorable safety profile in the real-world clinical practice setting."
The NovoTTF Therapy supplement can be accessed on the Seminars in Oncology website or via the links below. The supplement is comprised of the following articles:
Clinical Experience with NovoTTF-100A System for Glioblastoma: the Patient Registry Dataset (PRiDe)
Maciej M. Mrugala, Herbert H. Engelhard, David Dinh Tran, Yvonne Kew, Robert Cavaliere, John L. Villano, Daniela Annenelie Bota, Jeremy Rudnick, Ashley Love Sumrall, Jay-Jiguang Zhu, Nicholas Butowski
Response Patterns of Recurrent Glioblastomas Treated with Tumor Treating Fields (TTFields)
Josef Vymazal, Eric T. Wong
Post Hoc Analysis of Intention-to-Treat Population in Phase 3 Comparison of NovoTTF-100A System Versus Best Physician's Choice Chemotherapy
Andrew A. Kanner, Eric T. Wong, John L. Villano, Zvi Ram, on behalf of EF-11 Investigators
Alternating Electric Fields (Tumor Treating Fields Therapy) Can Improve Chemotherapy Treatment Efficacy in Non-Small Cell Lung Cancer Both In Vitro and In Vivo
Moshe Giladi, Uri Weinberg, Rosa S. Schneiderman, Yaara Porat, Michal Munster, Tali Voloshin, Roni Blatt, Shay Cahal, Aviran Itzhaki, Amir Onn, Eilon D. Kirson, Yoram Palti
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
The 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. NovoTTF Therapy is not approved for the treatment of non-small cell lung cancer in the United States. The safety and effectiveness of the therapy in this indication has not been established.
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.
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called NovoTTF Therapy. Novocure U.S. operations are based in Portsmouth, NH and New York, NY. The company also has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Peter Melnyk, Novocure
+1 (212) 767-7534
Ashley Cordova, Novocure
+1 (212) 767-7558