Recently, in December, 2014, the privately-held company Novocure announced extremely positive results for its Phase III trial in glioblastoma, the most common and aggressive type of brain tumor. Novocure’s EF-14 Phase III trial was terminated early because of early success in newly diagnosed glioblastoma patients. Novocure previously found similar success in a Phase III trial of recurrent glioblastoma patients in 2010.
Novocure’s Optune treatment (formerly called NovoTTF-100A) has been available in many countries since its 2010 Phase III success, and was approved by the US FDA in 2011 for recurrent glioblastoma. The non-invasive Optune treatment consists of a portable battery pack and circuitry connected to the patient’s scalp via electrodes. The electrodes deliver low intensity, alternating electric fields within the frequency range of 100-300 kHz. At this frequency, the electric fields can not be felt by the patients, and cause no harm to healthy cells. But after years of research in Israel, it was discovered that these frequencies cause apoptosis (cell death) in cancer cells.
While the treatment does require the patient to carry the equipment and affix electrodes to a shaved head, the treatment causes no pain or side effects, and is a classic example of the huge growth in transformational, paradigm-breaking cancer treatments the world has enjoyed over the past decade.
The EF-14 Phase III trial used Optune in 315 newly diagnosed glioblastoma patients with standard temozolomide treatment. The improvements in median progression-free survival (PFS) and overall survival (OS) were modest in actual time, but very significant relative to the aggressive nature of the disease. Most importantly, the long tail distribution showed 43% of patients still alive after 2 years from diagnosis, compared to only 29% with standard treatment. Standard chemo/radiation treatment for newly diagnosed glioblastoma patients has a median OS of only 14.2 months, so this form of cancer is in desperate need of new ideas and strategies. Over 10,000 people a year in the US alone are diagnosed with glioblastoma. Optune is now available at over 150 cancer centers in the US.
Novocure’s Optune device is a ground-breaking, paradigm-shifting, toxicity-free treatment for glioblastoma brain tumors. Optune has proven to have additive benefits when used with other treatments, giving more credence to the benefits of combined, multi-pronged treatment strategies.
In 2011, Novocure chairman Bill Doyle presented an overview of the Optune system’s mechanism at a TED conference.