Today, the final analysis of data from the EF-14 trial was published
in the Journal of the American Medical Association
). EF-14 was a pivotal, international phase 3 clinical trial that compared newly diagnosed glioblastoma patients using tumor-treating device, Optune, in combination with the chemotherapy temozolomide (Temodar) to those receiving temozolomide alone, following surgery and radiation therapy.
Interim results from this trial, first reported in November of 2014, warranted an independent review committee to recommend Novocure, Optune’s manufacturer, end the trial early so that patients on the control-arm could “cross-over” and receive treatment with the device, and to move forward for FDA approval.
In October 2015, the FDA did approve Optune for the treatment of adults with newly diagnosed glioblastoma in combination with temozolomide following standard treatment of surgery and radiation therapy. Optune, previously called NovoTTF-100A, had originally received FDA approval to treat recurrent adult glioblastoma patients in 2011.
The data published in JAMA today confirms, from long-term follow-up of the patients who had participated in the study, that the device is a safe and effective treatment option for glioblastoma patients – improving both overall and progression-free survival for patients by statistically significant margins.
NBTS, is pleased that long-term follow-up continues to provide positive data on the use of the Optune device. Glioblastoma has proven an extremely difficult therapeutic area, and the growing body of evidence related to Optune gives confidence to patients, their care partners, and advocates that this device is a viable option for the newly diagnosed – along with recurrent patients – to consider with their medical teams when selecting appropriate treatment plans based on their preferences and needs. We encourage patients to discuss this, and all treatment options, including clinical trials, with their oncologist.
Finally, as we said at the time of Optune’s approval, we also urge all health insurers to provide adequate coverage of Optune in both the newly-diagnosed and recurrent settings, as the cost of a new treatment should not be a barrier to care for patients with life-threatening illnesses, like glioblastoma. These patients need affordable access to all treatment options they may consider.
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Optune is a portable battery or power-supply operated device, which produces changing electrical fields, called tumor treatment fields (“TTFields”) intended to disrupt the growth of tumor cells. Patients wear a backpack containing the device’s battery and electrodes directly on their scalp. Optune is meant to be used continuously and under the supervision of a properly trained medical practitioner.