Tumor treating fields with temozolomide may increase PFS in patients with newly diagnosed glioblastoma

Adding tumor treating fields (TTFields) therapy to temozolomide significantly increases progression-free survival (PFS) for newly diagnosed glioblastoma patients versus giving temozolomide alone, according to data presented at 2014 Society for Neuro-Oncology (SNO) Annual Meeting, in Miami.

Additionally, the data indicate that the combination of treatments significantly increased median overall survival, as well as led to a 48% increase in the 2-year survival rate. These findings represent the first clinically and statistically meaningful improvement in survival rates for glioblastoma patients in almost a decade.

The data come from the interim analysis of the EF-14 study, a large phase 3 multinational randomized controlled trial. The trial was designed to test whether adding TTFields therapy to the current standard of care in glioblastoma treatment, which is surgery followed by radiation with concomitant temozolomide and then adjuvant temozolomide, could increase PFS (primary end point) and also whether the combination could increase overall survival (powered secondary endpoint). 

The study was randomized 2-to-1 for TTFields therapy and standard of care versus standard of care alone.  The trial was designed to enroll 700 patients, and the interim analysis was completed when 315 patients were available for 18 months of follow-up data.  Based on the interim analysis of the study, the independent data monitoring recommended that the trial be stopped and that patients treated on the active control arm be crossed over to receive TTFields therapy. 

TTFields therapy is delivered as durable medical equipment supplied by Novocure Inc., the US subsidiary of Novocure, the manufacturer of the system and trial sponsor. 

The trial was sponsored by Novocure.

Glioblastoma affects between 10,000 and 12,000 Americans each year. The disease is aggressive and patients must have access to the full standard of care treatment options (surgery, radiation, chemotherapy and TTFields therapy) to achieve optimal outcomes. 

“Medical benefit managers within managed care plans should notify case managers that glioblastoma patients may seek coverage for TTFields therapy under the durable medical equipment benefit,” said Eilon Kirson, MD, PhD, chief science officer and head of research and development at Novocure.

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