ANAHEIM, Calif., Nov. 21, 2011 /PRNewswire/ -- Novocure™, a commercial stage private oncology company, announced today that Dr. Eric T. Wong, Co-Director, Brain Tumor Center, Beth Israel Deaconess Medical Center in Boston, presented follow-up results of a study focusing on overall survival in patients with recurrent glioblastoma multiforme (GBM). The long-term follow-up results from the Phase III EF-11 study compared overall survival at two and three years after initiating therapy in patients with recurrent GBM who were treated with Tumor Treating Fields™ (TTF) therapy versus best standard of care chemotherapy. The results were presented at the 16th Annual Scientific Meeting of the Society for NeuroOncology in Anaheim.
The presentation described the updated survival data two years after completing recruitment of a study comparing either continuous TTF monotherapy (20-24 hours per day, 7 days a week) or best standard of care chemotherapy based on physician choice. The primary endpoint of the Phase III study was overall survival and secondary endpoints were PFS6, radiological response rate and quality of life. The study was conducted at 28 U.S. and European-based centers.
With a median follow-up of 39 months, overall survival in the TTF group compared to the best standard of care chemotherapy group at two and three years of follow-up was 9% vs. 7% and 8% vs. 1%, respectively ( p=ns). The study also showed trends in favor of TTF compared to chemotherapy in PFS6 (21.4% vs. 15.2%, respectively, p=ns) and radiological response rates (14.0% vs. 9.6%, respectively, p=ns). Finally, patients in the TTF group had many less grade 2 or higher side effects and their quality of life was better than patients receiving chemotherapy.
"We are pleased to report that TTF therapy, a non-invasive, novel cancer treatment modality showed impressive therapeutic efficacy with promising long-term survival results in our patients, "said Dr. Wong. "We are encouraged by our findings that TTF therapy will find a critical role in the treatment of patients with recurrent GBM."
"The results of this long term follow up continue to validate the promise that NovoTTF™ therapy provides to the thousands of patients who suffer from recurrent GBM," said Asaf Danziger, CEO of Novocure. "We will continue to investigate the potential of this innovative treatment in other types of solid tumor cancers and look forward to sharing our results with the medical community in the future."
Glioblastoma multiforme (GBM) is the most aggressive and most common form of primary brain tumor in the U.S. The disease affects approximately 10,000 Americans each year. The median overall survival time from initial diagnosis is 15 months with optimal treatment, and median survival from the time of tumor recurrence is only 3-5 months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
About the NovoTTF-100A System™
NovoTTF-100A System™ is a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device has been shown in in vitro and in vivo studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A device, which weighs about six pounds (three kilograms), creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. In patients with recurrent glioblastoma brain tumors, the device has shown clinical efficacy comparable to that of active chemotherapies with better quality of life without many of the side effects of chemotherapy. The NovoTTF-100A has received marketing approval in the US and is a CE Marked device that is cleared for sale in Europe.
The US Food and Drug Administration (FDA) has approved the NovoTTF-100A System for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically – or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device 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 device.
Novocure™ Limited is a private oncology company pioneering a novel therapy for solid tumors. Novocure's worldwide headquarters is located in the Jersey Isle. Novocure's US operations are based in Portsmouth, NH and the company's research center is located in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Dr. Eric T. Wong received research grants from Novocure, Inc. He has complete access to the research data from the EF-11 clinical trial and the results of the data analysis.