Head patch device Optune improves brain cancer survival
A head patch device that delivers alternating electrical fields to the brain has been shown to significantly improve survival in newly diagnosed glioblastoma patients.
Developed by Jersey, US-based Novocure, Optune beams so-called Tumour Treating Fields (TTFs) through the scalp and into brain tumours where they disrupt cell division. Because of the shifting direction of TTFs, healthy brain tissue is left unaffected.
In data from a pivotal phase 3 trial, EF-14, the addition of Optune to standard of care chemotherapy (temozolomide) significantly improved overall survival at two and five years in a sample of 695 glioblastoma (GBM) patients.
Two-year survival increased from 30% to 43% and five-year survival from 5% to 13% when Optune was used alongside temozolomide compared to those given chemotherapy alone.
The results are the most significant increases in both survival rates reported in a phase 3 trial for newly diagnosed GBM.
Median overall survival was also improved in the Optune plus temozolomide group from 15 months to 21 months.
“When I started treating patients with GBM 20 years ago, the majority of patients died within less than one year and long-term survival was nearly absent. Now, we see a meaningful improvement in survival at two years and beyond,” said Roger Stupp, principal investigator for the study. “With the combination of Optune and temozolomide, one out of seven patients is living longer than five years.”
“This is the first positive phase 3 trial in newly diagnosed GBM since we demonstrated the efficacy of temozolomide in 2005, establishing it as a standard first-line therapy."
Novocure is also investigating Optune in recurrent ovarian cancer where most recent phase 2 data indicated its safety and tolerability when combined with paclitaxel.
When compared with then-current phase 3 data investigating paclitaxel treatment alone in recurrent ovarian cancer, Optune plus paclitaxel almost doubled progression-free survival as well as improving overall survival.
“These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM,” said Asaf Danziger, CEO of Novocure. “The efficacy shown in EF-14 for GBM gives us hope that TTFields used in combination other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumours.”
Optune originally earned FDA approval in 2011 for recurrent glioblastoma before being given an expanded indication for first-line treatment of GBM in combination with temozolomide in 2015.
