Novocure Announces the EF-14 Phase III Clinical Trial of Tumor Treating Fields in Patients with Newly Diagnosed Glioblastoma has been Terminated at the Interim Analysis due to Early Success

-- Data presented today as a late-breaking abstract at the Society for Neuro-Oncology 2014 Annual Meeting in Miami demonstrated the EF-14 trial met its primary endpoint of progression-free survival and secondary endpoint of overall survival in a planned analysis

-- The EF-14 trial Independent Data Monitoring Committee recommended terminating the trial early and allowing all control patients to receive Tumor Treating Fields

ST. HELIER, Jersey, Nov. 15, 2014 /PRNewswire/ -- Novocure™, a commercial stage oncology company, announced today that Tumor Treating Fields (TTFields) delivered by the NovoTTF™-100A System in combination with standard-of-care temozolomide chemotherapy extended both progression-free survival (PFS) and overall survival (OS) compared to temozolomide alone in patients with newly diagnosed glioblastoma (GBM). The late-breaking, EF-14 Phase III trial data were presented today at the Society for Neuro-Oncology (SNO) 2014 Annual Meeting in Miami, Florida by Dr. Roger Stupp, Professor and Chairman, Department of Oncology and Director, University Hospital Cancer Center, University of Zurich, Zurich, Switzerland.

The pre-specified, interim analysis of EF-14 trial data was conducted on the first 315 patients, representing approximately 50 percent of the targeted study population. The data show that:

• Patients treated with TTFields together with temozolomide demonstrated a significant increase in progression free survival compared to temozolomide alone (median PFS of 7.1 months compared to 4.0 months, respectively, hazard ratio=0.63, p=0.001).
• Patients treated with TTFields together with temozolomide demonstrated a significant increase in overall survival compared to temozolomide alone (median OS of 19.6 months compared to 16.6 months, respectively, hazard ratio=0.75, p=0.034).
• The percentage of patients alive at 2 years in the TTFields together with temozolomide arm was 43% compared to 29% in the temozolomide alone arm.

Based on the interim analysis results, the Independent Monitoring Committee (IDMC) for the EF-14 trial recommended that the trial be stopped early and that Novocure provide access to TTFields for patients on the temozolomide alone arm.

"These results are spectacular," said Dr. Roger Stupp, M.D., Director of the University Hospital Cancer Center at the University of Zurich, Zurich, Switzerland and EF-14 Principal Investigator. "A new standard of care for patients suffering from glioblastoma is born."

"The results presented today by Dr. Roger Stupp set the stage for establishing TTFields therapy as a major modality in solid tumor cancer treatment," said William Doyle, Executive Chairman of Novocure. "Achieving statistically-significant and clinically meaningful results in both overall survival and progression-free survival is a fantastic outcome for the GBM patients we serve. I extend my sincere thanks to patients and investigators in the EF-14 trial and to the many supporters who have helped us achieve this important milestone."

"We are very pleased with the EF-14 results and are working to make the TTFields therapy available to newly diagnosed glioblastoma patients throughout Europe and Switzerland," said David Stocker, M.D., Novocure's European general manager. "Novocure remains committed to supporting glioblastoma patients in their battle against cancer."

Certified Prescribers
The NovoTTF-100A System is available at the following leading cancer centers in the European Union and Switzerland:

Austria
Vienna: Ordinationszentrum Döbling, Dr. M. Preusser

Czech Republic
Prague: Na Homolce Hospital, Dr. J. Šroubek

England
London: Cromwell Hospital, Dr. C. Lindquist

France
Lyon: Hospices Civils de Lyon, Dr. J. Honnorat
Paris: Groupe Hospitalier Pitié Salpêtrière, Dr. J.-Y. Delattre

Germany
Düsseldorf: Universitätsklinikum, Dr. M. Sabel, and Unit CME Düsseldorf, Dr. F. Ulrich
Duisburg: Klinikum Duisburg/Wedau Kliniken, Dr. M. Scholz
Hamburg: Universitätsklinikum Hamburg-Eppendorf, Dr. M. Westphal
Heidelberg: Universitätsklinikum, Dr. W. Wick
Kiel: Universitätsklinikum Schleswig-Holstein, Dr. H.M. Mehdorn
Regensburg: Universitätsklinikum, Dr. A. Brawanski
Saalfeld: Onkologische Praxisklinik MVZ MP Saalfeld, Dr. K. Fenchel
Ulm: Neurologische Universitätsklinik, Universitätsklinik Ulm/RKU, Dr. J. Lewerenz

Greece
Athens: Hygeia Hospital, Dr. E. Razis

Switzerland
Lausanne: Centre Hospitalier Universitaire Vaudois, Dr. A. Hottinger
Zurich: Zurich University Hospital, Dr. R. Stupp

About Glioblastoma
Glioblastoma (GBM) is the most common form of primary brain cancer with approximately 15,000 patients diagnosed each year in Europe. Overall survival with standard of care temozolomide chemotherapy alone is approximately 15 months.

About the NovoTTF-100A System
The NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that the NovoTTF-100A System slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The NovoTTF-100A System creates a low intensity, alternating electric field within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

The NovoTTF-100A System is approved in the European Union and Switzerland for the treatment of glioblastoma.

Approved Indication
The NovoTTF-100A device is intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

The NovoTTF-100A device is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

About Novocure
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.

Media and Investor Contact:
Ashley Cordova, Novocure
acordova@novocure.com
+1-212-767-7558

Related Links

http://www.novocure.com