Professor Zvi Ram Presents Phase III Recurrent Glioblastoma Survival and Quality of Life Data from the First Pivotal Study of the NovoTTF-100A at the 15th Annual Society for Neuro-Oncology (SNO) Scientific MeetingBy Novocure, PRNE
Thursday, November 18, 2010
MONTREAL, November 19, 2010 - 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
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 U.S., 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
Patients under the age of 60 who were able to maintain normal daily
activities (KPS greater than or equal to 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 U.S., 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
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 U.S. 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.
Novocure is a subsidiary of Jersey Isle based Standen Ltd., an oncology
company pioneering Tumor Treating Fields (TTF) therapy, a new modality for
treating solid tumors. Novocure's U.S. operations are based in Portsmouth, NH
and the company's research center is located in Haifa, Israel. For additional
information about the ongoing phase III trial for newly diagnosed
glioblastoma patients, please visit www.novocuretrial.com.
For additional information about the company, please visit
Contact: Frank Leonard, Novocure email@example.com Phone: +1-917-656-3518
Frank Leonard of Novocure, +1-917-656-3518, frank at novo-cure.com / NOTE TO EDITORS: High resolution device photos available by request.
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