Novocure Reports Data Showing TTF Therapy in Combination With Chemotherapy Has the Potential to Increase Overall Survival for Patients With Advanced Non-Small Cell Lung Cancer
By Novocure, PRNESaturday, October 9, 2010
Data Presented Today at the 35th European Society for Medical Oncology Congress
MILAN, October 10, 2010 - Novocure reported today that patients with advanced non-small cell lung
cancer (NSCLC) achieved a significant increase in survival time when tumor
treating fields (TTF) therapy was added to chemotherapy, as compared to
previously reported outcomes for patients receiving chemotherapy alone. Dr.
Miklos Pless, head of medical oncology at the Winterthur Hospital Cancer
center in Switzerland, presented the data at the European Society for Medical
Oncology Congress (ESMO).
Physicians delivered (TTF) Therapy to patients in the study using the
NovoTTF-100L–a portable, non-invasive medical device. Investigators
conducted this single arm, phase II study at four centers in Switzerland,
enrolling 42 patients with locally advanced and metastatic NSCLC (stage
IIIb-IV) who had failed prior treatments with chemotherapy. Patients in the
study received TTF Therapy for 12 hours a day in combination with pemetrexed
(Alimta; Eli Lilly) until disease progression.
Advanced NSCLC is the second cancer in which TTF Therapy has shown
clinical efficacy in human trials. Novocure reported a successful phase III
clinical trial of TTF monotherapy in patients with recurrent glioblastoma, an
aggressive form of brain cancer, at the American Society for Clinical
Oncology Conference (ASCO) earlier this year. Results of this phase III trial
have been filed with the U.S. Food and Drug Administration (FDA).
"We were pleased to report on the results of this multi-center trial of
TTF Therapy in a non-brain tumor indication," said Dr. Pless. "We believe
this study has shown TTF Therapy to be completely non-toxic and to have the
potential to act as a significant adjunct to chemotherapy in the treatment of
NSCLC and other solid tumor indications."
Patients treated with TTF Therapy in combination with pemetrexed had a
median overall survival time of 13.8 months compared with the 8.3 months
reported for pemetrexed alone. The one-year survival rate for the combination
was 57 percent compared with the 30 percent reported for pemetrexed alone.
Progression-free survival more than doubled when TTF Therapy was added to
pemetrexed, to 22-28 weeks versus the 12 weeks previously reported for
pemetrexed alone(1). The only reported adverse event for TTF Therapy was mild
to moderate skin irritation at the treatment site.
"These NSCLC data further validate TTF Therapy as a viable approach to
treating deadly cancers," said Asaf Danziger, chief executive officer of
Novocure. "We have seen positive clinical success in both phase II and phase
III studies, alone and in combination with chemotherapy, and believe TTF
Therapy has the potential to be effective in a range of solid tumors."
TTF Therapy slows and reverses tumor cell proliferation by inhibiting
mitosis, the process by which cells divide and replicate themselves. The
NovoTTF-100L 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's NovoTTF-100A device has received its CE Mark and is approved
for sale in six European countries as a treatment for glioblastoma brain
tumors. The NovoTTF-100L device has received its CE Mark as a treatment for
NSCLC and will be launched in Europe in the near future. Novocure is also
planning to file an investigational device application with the FDA for a
phase III study of TTF Therapy in early stage NSCLC in the near future.
ABOUT NOVOCURE
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 Novocure, please visit www.novocuretrial.com.
(1) Nasser Hanna et al; "Randomized Phase III Trial of Pemetrexed versus
Docetaxel in Patients with Non-Small-Cell Lung Cancer Previously Treated With
Chemotherapy," Journal of Clinical Oncology 22.9 (2004): pp 1589-1597
Contact: Mike Ambrogi, Novocure mike@novo-cure.com Phone: +1-603-944-7445 Frank Leonard, Novocure frank@novo-cure.com Phone: +1-917-656-3518
Mike Ambrogi, +1-603-944-7445, mike at novo-cure.com, or Frank Leonard, +1-917-656-3518, frank at novo-cure.com, both of Novocure, EDITORS NOTE: High resolution device photos available by request.
Tags: Milan, Novocure, October 10, Western Europe