Date: 2014-11-15
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the Society for Neuro-Oncology (SNO) 2014 Annual Meeting inMiami, Florida
Company: Novocure (UK)
Product: NovoTTF™-100A System in combination with standard-of-care temozolomide
Action
mechanism: 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 experimental for the treatment of newly diagnosed glioblastoma in the U.S. and is limited by law to investigational use only.
The NovoTTF-100A System has received marketing approval in the U.S. under the brand name Optune™ for recurrent GBM. The NovoTTF-100A System is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.
Disease: glioblastoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 15, 2014, Novocure, a commercial stage oncology company, announced 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 at the Society for Neuro-Oncology (SNO) 2014 Annual Meeting inMiami, 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. Novocure is in discussions with the FDA regarding the regulatory pathway for TTFields in newly diagnosed GBM.
