JAMA Publishes Final Analysis of EF-14 Phase 3 Pivotal Trial of Optune® Together with Temozolomide Demonstrating Unprecedented Survival Results for Newly Diagnosed Glioblastoma
The EF-14 trial is the first trial in over a decade to demonstrate statistically and clinically significant extension of overall survival of patients with newly diagnosed glioblastoma regardless of patient characteristics
ST. HELIER, Jersey–(BUSINESS WIRE)–
“This is the first positive phase 3 trial in newly diagnosed GBM since the efficacy of temozolomide was demonstrated in 2005,” said EF-14 Investigator
The multi-national, randomized, open-label trial included 695 newly diagnosed GBM patients who were enrolled at 83 centers from
The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase 3 trial to date and represent a new landmark for five-year survival rate in this difficult to treat disease.
The overall survival benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups including subgroups with the worst prognosis who have benefitted less from previous therapies – patients 65 years of age or older and patients with unmethylated MGMT promoter. There was no increase in systemic adverse events from Optune plus temozolomide versus temozolomide alone. The only common adverse reaction from Optune treatment noted in the final analysis was mild to moderate skin irritation beneath the system’s transducer arrays.
“GBM is a very difficult to treat disease where over 20 large randomized phase 3 studies have failed to show a survival benefit over the past decade. We are proud of the EF-14 final analysis and what it means to patients living with GBM,” said
Headquartered in Jersey,
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Important Safety Information
Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by
Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.
Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
Patients should only use Optune under the supervision of a physician properly trained in use of the device.
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