Novocure Announces the Presentation of Subgroup Survival Data for Recurrent Glioblastoma Patients Treated with NovoTTF(TM) Therapy
Analysis of PRiDe, a U.S. commercial registry of 457 recurrent glioblastoma patients, demonstrates that patients treated with NovoTTF Therapy at their first recurrence achieved a median overall survival of 20 months
NEW YORK, June 13, 2014 /PRNewswire/ — Novocure, a commercial stage oncology company, announced today that subgroup survival data from its U.S. commercial patient registry will be presented at the 16(th) Biennial Canadian Neuro-Oncology Meeting in Halifax, Nova Scotia, on June 14, 2014. The U.S. patient registry, called PRiDe, includes data from every recurrent glioblastoma patient treated with NovoTTF Therapy from October 2011 through November 2013 at 91 leading oncology centers in the United States (n=457).
PRiDe subgroup analyses demonstrate that recurrent glioblastoma patients treated with NovoTTF Therapy in the real-world setting at first or second recurrence experienced a significantly longer median overall survival (OS) compared to patients treated at third or subsequent recurrences (median OS of 20.0 months and 8.5 months compared to 4.9 months, respectively, p<0.0001). In addition, the median survival of bevacizumab-naive recurrent glioblastoma patients treated with NovoTTF Therapy was significantly longer compared to recurrent glioblastoma patients treated with bevacizumab prior to receiving NovoTTF Therapy (median OS 13.4 months versus 7.2 months, respectively, p=0.0001).
Details of the oral abstract presentation are as follows:
Abstract C7: NovoTTF-100A Alternating Electric Fields Therapy for Recurrent Glioblastoma: An Analysis of Patient Registry Data
Date: Saturday, June 14, 2014
Presenter: Eric. T. Wong
Session: Clinical Oral Presentations, Session 5
Venue/Time: Pier 21- Heritage Hall/ 1pm EST
The analysis of the PRiDe U.S. patient registry data was conducted by physicians from leading oncology research institutions. 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 Carolinas HealthCare System's Levine Cancer Institute, Charlotte, NC Dr. Jay-Jiguang Zhu University of Texas Health Science Center at Houston, Houston, TX
“Data from this real-life patient registry indicate that NovoTTF Therapy is an effective and very well- tolerated treatment option for patients with recurrent glioblastoma,” said lead author of the study, Eric. T. Wong, Director of the Neuro-Oncology Unit at Beth Israel Deaconess Medical Center. “The subgroup data are of particular clinical importance and strongly suggest that treating patients with NovoTTF Therapy at the earliest time point after recurrence offers the best chance for improving overall survival with very minimal side effects.”
“Novocure is a global leader in glioblastoma research and treatment, and we are 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 PRiDe dataset demonstrated a median overall survival of 9.6 months for all patients, which is the longest median survival yet shown in a non-experimental treatment setting for recurrent glioblastoma, and confirms that NovoTTF Therapy can be used safely and effectively in the real-world environment.”
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 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 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 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