Novocure, a commercial stage oncology company, has 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 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.

Novocure is in discussions with the United States Food and Drug Administration (FDA) regarding the regulatory pathway for TTFields in newly diagnosed GBM.

“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.

“The results presented today by Dr Roger Stupp set the stage for establishing TTFields therapy as a major modality in solid tumour 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.”

Source: Novocure