Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM).

According to Novocure’s press release, the final results of the EF-14 clinical trial indicated a two-year survival rate of 43% for patients treated with the Optune device in addition to conventional temozolomide (TMZ) chemotherapy, versus a two-year survival rate of 30% for patients treated with TMZ alone.  Novocure also reported that the addition of the Optune device to the standard TMZ treatment resulted in a five-year survival rate increase from 5% to 13% and a median overall survival extension from 15 months to 21 months. The press release noted that these results were seen across all patient subgroups, including young versus elderly patients, patients with methylated versus unmethylated MGMT promoter and patients who underwent any extent of tumor resection.

EF-14 Principal Investigator Roger Stupp, M.D., stated:

Now, we see a meaningful improvement in survival at two years and beyond.  With the combination of Optune and temozolomide, one out of seven patients is living longer than five years.

Optune is advertised as being a wearable device that uses transducer arrays adhered to the scalp to deliver tumor treating fields (TTFields), a form of alternating electric field therapy, to inhibit division of GBM cells. According to Novocure, Optune has been FDA approved for treatment of newly diagnosed GBM since 2015, and for treatment of recurrent GBM since 2011.  According to Novocure CEO Asaf Danziger, the “efficacy shown in EF-14 for GBM gives us hope that TTFields used in combination with other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.”  Dr. Stupp added that TTFields “may well be suited for combination with conventional treatments for many other cancer types.”