Combination of Optune™ with Standard of Care Chemotherapy, Temozolomide, Provides Landmark Five-Year Survival Rates for Newly Diagnosed Glioblastoma Patients
Final analyses provide unprecedented five-year survival advantage reinforcing Optune plus temozolomide as a combination treatment for glioblastoma patients
Survival benefit was maintained in all patient subgroups, including those with the worst prognostic features
ST. HELIER, Jersey–(BUSINESS WIRE)–
The two-year survival rate increased from 30 percent to 43 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. 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 clinically meaningful increases in landmark survival rates (hazard ratio, 0.63; p<0. 00006).
EF-14 Principal Investigator
“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,” Dr. Stupp said. “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,” continued Dr. Stupp. “Beyond GBM, I believe this trial establishes an entirely different approach to cancer treatment with minimal toxicity which may be well suited for combination with conventional treatments for many other cancer types.”
GBM is the most common form of primary brain cancer. An estimated 12,500 people are diagnosed with GBM in
“We are excited that combination therapy with Optune plus temozolomide continues to show a meaningful extension of long-term survival for newly diagnosed GBM patients,” said
The data presented confirmed that the overall survival benefit of Optune together with temozolomide compared to temozolomide alone was 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. The data showed a safety profile consistent with previous reports of data from the study.
“These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM,” said
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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 in the US or by email at supportEMEA@novocure.com in the
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.
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