NovoCure announces results of Phase III trial of Tumor Treating Fields + temozolomide for glioblastoma.

Novocure, a commercial stage oncology company, announced that the first analysis of all 700 newly diagnosed glioblastoma (GBM) patients enrolled in its EF-14 Phase III trial confirms that Tumor Treating Fields (TTFields) delivered in combination with standard-of-care temozolomide chemotherapy extends both progression-free survival (PFS) and overall survival (OS) compared to temozolomide alone in patients with newly diagnosed GBM.

The full dataset analysis will be presented on June 2 at the 2015 Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois by Dr. Roger Stupp, Professor and Chairman, Department of Oncology and Director, University Hospital Cancer Center, University of Zurich, Zurich, Switzerland.

A pre-specified, interim analysis of EF-14 trial data conducted on the first 315 patients concluded that the trial met its endpoints of superior progression free and overall survival. The analysis of the full trial cohort of 700 patients confirms these conclusions. The results of the analysis of the full trial cohort show that: The percentage of patients alive at two years when treated with TTFields together with temozolomide was 43% (95% confidence interval 36-50%) compared to 29% (95% confidence interval 21-38%) when treated with temozolomide alone. 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 4.2 months, hazard ratio=0.69, p=0.001). Patients treated with TTFields together with temozolomide demonstrated a significant increase in overall survival compared to temozolomide alone (median OS from randomization of 19.4 months compared to 16.6 months, hazard ratio=0.75, p=0.022).

Comment: The FDA approved Optune for recurrent glioblastoma patients in 2011, and Novocure seeks to use the device in newly diagnosed cases as well.