-- A registry of 457 recurrent glioblastoma patients shows that patients treated commercially with NovoTTF Therapy in 2012 and 2013 achieved the longest median overall survival yet shown in non-experimental use for patients with recurrent glioblastoma
NEW YORK, May 19, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today that an analysis of the efficacy and safety data from its U.S. patient registry will be published as part of the 50th meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL from May 30 – June 3, 2014. The U.S. patient registry included data for all recurrent glioblastoma patients treated with NovoTTF Therapy from October 2011 to November 2013 at 91 leading oncology centers in the United States (n=457).
Based on the patient registry data, recurrent glioblastoma patients treated with NovoTTF Therapy achieved a median overall survival of 9.6 months, which is the longest median overall survival yet shown in non-experimental use for patients with recurrent glioblastoma. The registry data also indicate that the adverse event profile of NovoTTF Therapy is benign, consistent with the findings from the therapy's registration trial. Details of the abstract and presentation can be found online athttp://abstract.asco.org/:
NovoTTF-100A Alternating Electric Fields Therapy for Recurrent Glioblastoma: An Analysis of Patient Registry Data
Abstract number: e13033
The analysis of the U.S. patient registry data was conducted by physicians from leading academic institutions for oncology research. The authors of the publication are:
Dr. Eric T. Wong –Brain Tumor Center and Neuro-Oncology Unit, Beth Israel Deaconess Medical Center, Boston, MA
Dr. Herbert H. Engelhard-University of Illinois Hospital and Health Sciences System, Chicago, IL
Dr. David D. Trinh Tran- Washington University School of Medicine, St. Louis, MO
Dr. Yvonne Kew-Houston Methodist Hospital, Houston, TX
Dr. Maciej M. Mrugala- University of Washington, Seattle, WA
Dr. Robert Cavaliere-The Ohio State University, Columbus, OH
Dr. John L. Villano-University of Kentucky, Lexington, KY
Dr. Daniela Annenelie Bota-University of California, Irvine Medical Center, Orange, CA
Dr. Jeremy Rudnick-Neuro-Oncology Program, Cedars-Sinai Medical Center, Los Angeles, CA
Dr. Ashley Love Sumrall-Levine Cancer Institute, Charlotte, NC
Dr. Jay-Jiguang Zhu-University of Texas Health Science Center at Houston, Houston, TX
"Data from this registry are very encouraging and indicate that NovoTTF Therapy may be an effective treatment for some patients with recurrent glioblastoma. This therapy is very well tolerated and could be offered as a therapeutic option to patients experiencing recurrence of the disease," said study author Dr. Maciej M. Mrugala, MD, Ph.D, MPH Alexander M. Spence Endowed Chair in Neuro-Oncology, and Chief, Division of Neuro-Oncology, University of Washington School of Medicine. "These data show that in real life use of NovoTTF Therapy, survival of recurrent glioblastoma patients is approximately 50% longer than what was seen in both arms (NovoTTF therapy arm and chemotherapy control arm) of the therapy's registration trial."
"Novocure is committed to providing physicians and patients with the data necessary to make informed decisions about NovoTTF Therapy," said Eilon Kirson, MD, Ph.D., Chief Science Officer and Head of Research and Development at Novocure. "The registry data of 457 patients provide physicians and patients with evidence to confirm that NovoTTF Therapy can be used safely and effectively in the real world setting outside clinical trials."
Glioblastoma 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 vivostudies 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 weighs about six pounds (three kilograms) and 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.
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. Additionally, the company has offices inSwitzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visitwww.novocure.com.
Peter Melnyk, Novocure