November 19, 2010
Professor Zvi Ram Presents Phase III Recurrent Glioblastoma Survival And Quality Of Life Data From The First Pivotal Study Of The NovoTTF-100A At 15th Annual Society For Neuro-Oncology Scientific Meeting
Data presented today from a pivotal, phase III randomized clinical trial for patients with recurrent glioblastoma tumors suggest that Tumor Treating Fields (TTF) therapy may increase median survival time and improve quality of life scores compared to best standard of care chemotherapy. Professor Zvi Ram, chairman of the Department of Neurosurgery at Tel-Aviv Sourasky Medical Center, presented the data at the Society for Neuro-Oncology (SNO) Annual Scientific Meeting.
Physicians delivered the investigational TTF therapy to patients in the study using the NovoTTF-100A "“ a portable, non-invasive medical device. Investigators conducted this phase III study under an approved IDE at 28 centers in the US, Europe, and Israel, enrolling 237 patients with glioblastoma tumors that had recurred or progressed after initial treatment. Patients randomly received TTF therapy alone or an effective chemotherapy selected by physicians. The results reported today expand on headline data from the trial presented at the American Society for Clinical Oncology (ASCO) Annual Meeting in June 2010, which suggested that TTF therapy may be as effective as the best available chemotherapy in extending overall survival of patients with recurrent GBM.
"The study suggests that patients treated with TTF therapy, as defined in the protocol, lived significantly longer than patients treated with the currently available best chemotherapeutic regimens," said Professor Ram. "Interestingly, younger patients and patients with better functional status appear to have an impressive survival advantage. In these patients the incidence of radiological tumor response to TTF therapy was double that seen in patients treated with chemotherapy. Most importantly, in addition to the survival benefit, treatment with TTF therapy was associated with significantly better quality of life compared to patients receiving chemotherapy."
Patients under the age of 60 who were able to maintain normal daily activities (KPS>80 percent) at the time of enrollment achieved a significant increase in median overall survival time (8.8 vs. 6.6 months, n=110, p< 0.01) and in the 1-year survival rate (35 percent vs. 20 percent, n=110, p< 0.01) when treated with TTF Therapy versus effective chemotherapies. TTF therapy also produced a significant increase in survival time for patients who had failed treatment with bevacizumab (Avastin; Roche) prior to enrollment (4.4 vs. 3.1 months, n=44, p< 0.02). Patients enrolled in the study also reported superior quality of life scores (EORTC QLQ-C30) across a range of lifestyle and symptom categories for TTF therapy compared to the chemotherapy-treated control group.
"The data presented at SNO further validate TTF therapy as a potential treatment option for patients with recurrent glioblastoma tumors," said Asaf Danziger, chief executive officer of Novocure, the trial sponsor. "The suggested improvement in quality of life scores reported by patients receiving TTF therapy is particularly important given the nature of this disease and the strong desire among patients and their caregivers to avoid the side-effects of chemotherapy and radiation."
TTF therapy has been shown in vitro to slow and reverse tumor cell proliferation 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.
Novocure is now sponsoring a second phase III study of TTF therapy at 26 centers in the US, Europe, and Israel. This study will enroll 283 patients with newly diagnosed glioblastoma tumors. Patients will be randomized (2 to 1) to receive TTF therapy and temozolomide (Temodar; Merck & Co) or temozolomide alone (the current best standard of care).
Novocure also recently reported results from a successful phase II trial that studied TTF therapy in combination with chemotherapy for advanced non-small cell lung cancer at the European Society of Medical Oncology Congress.
The NovoTTF-100A is an investigational device in the United States and has not been approved by the U.S. Food and Drug Administration (FDA) for sale in the US for any use. Results of this phase III trial for recurrent glioblastoma patients have been submitted in a premarket approval application, which is under review by FDA. Novocure currently has CE Mark for the NovoTTF-100A and the treatment is available to patients in Europe.
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