On November 20, Novocure announced that long-term follow-up results from the Phase III EF-11 investigation that focused on overall survival in individuals who suffer with recurrent glioblastoma multiforme (GBM), were presented by Dr. Eric T. Wong, Co-Director, Brain Tumor Center, Beth Israel Deaconess Medical Center in Boston. The study compared overall two and three year survival rates after patients with recurrent GBM started treatment with Tumor Treating Fields (TTF) therapy, compared to best standard of care chemotherapy.
The results were presented at the 16th Annual Scientific Meeting of the Society for NeuroOncology in Anaheim.
Wong presented the updated survival data two years after enrollment of all study participants that compared either best standard of care chemotherapy based on physician choice or continuous TTF monotherapy (20-24 hours daily, 7 days a week) was completed.
The human study was carried out at 28 U.S. and European-based centers. Overall survival was the primary endpoint of the Phase III investigation, while secondary endpoints were, radiological response rate, quality of life and PFS6.
Participants were followed-up for a median of 39 months. When comparing participants who received best standard of care chemotherapy to those that received TTF, overall survival at two and three years of follow up was 7% vs. 9% and 1% vs. 8%, respectively ( p=ns).
Furthermore, in PFS6 the researchers reported trends in favor of TTF in comparison to chemotherapy (21.4% vs. 15.2%, respectively, p=ns) as well as in radiological response rates (14.0% vs. 9.6%, respectively, p=ns).
Wong explained that among the participants in the TTF group, there were considerably fewer higher adverse effects than those who received chemotherapy. Quality of life measures were also superior in the TTF group.
Dr. Wong explained:
“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. We are encouraged by our findings that TTF therapy will find a critical role in the treatment of patients with recurrent GBM.”
Asaf Danziger, CEO of Novocure, said:
“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.
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.”
Each year, around 10,000 U.S. individuals are affected with Glioblastoma multiforme (GBM), the most prevalent and aggressive type of primary brain tumor in the United States.
GMB is also widely recognized as one of the most aggressive and deadly forms of cancer.
From diagnosis median overall survival time is 15 with optimal treatment, and median survival from the time of tumor recurrence is only 3-5 months without additional effective treatment.
NovoTTF-100A System™ is a portable, non-invasive medical device designed for patients to continually use throughout the day. In vitro and in vivo investigations the device has shown to slow and reverse the growth of tumors by preventing the process by which cells divide and replicate (mitosis).
The device weights approximately six pounds (3 kg), and creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, stopping the normal mitotic process and causing cancer cells to die before they divide.
In individuals who suffer with recurrent GBM, the device has demonstrated clinical efficacy similar to that of active chemotherapies with better quality of life, without several of the adverse effects of chemotherapy. In the U.S. the device has received marketing approval and is a CE Marked device that is approved for sale in Europe.
The device has been approved by The U.S. Food and Drug Administration (FDA) for use as a treatment for individuals aged 22+ with with histologically-confirmed glioblastoma multiforme (GBM), following histologically – or radiologically-confirmed recurrence in the supra-tentorial area of the brain after receiving chemotherapy. Individuals should only use the device under supervision of a physician properly trained in use of the device. The NovoTTF-100A System is intended to be used a monotherapy, and as an alternative to standard medical therapy for GMB after radiation and surgical options have been exhausted.
Written by Grace Rattue