A phase III trial of Tumor Treating Fields was terminated early following early success detailed in an interim analysis. The trial evaluated patients with newly diagnosed glioblastoma being treated with the NovoTTF-100A System, developed by Novocure, in combination with standard-of-care temozolomide.
The treatment extended both progression-free survival and overall survival compared to temozolomide alone. The trial’s independent data monitoring committee recommended terminating the trial early and allowing all control patients to cross over to the treatment arm.
The trial data were presented at the annual meeting of the Society for Neuro-Oncology in Miami. 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.
Patients treated with Tumor Treating Fields together with temozolomide demonstrated a median progression-free survival of 7.1 months compared to 4.0 months with temozolomide alone (HR=0.63, p=0.001). Median overall survival was 19.6 months compared to 16.6 months in the control arm (HR=0.75, p=0.034).
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 system is approved in the European Union and Switzerland for the treatment of glioblastoma. The device is intended for the treatment of adult patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease.
