Treatment for glioblastoma (GBM)
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Optune® Novocure™
Unprecedented 5-year survival results in newly diagnosed GBM1

Optune + TMZ demonstrated superior long-term survival compared to TMZ alone1

5-year survival analysis of all 695 patients in EF-14 confirmed superior OS and PFS vs TMZ alone1,*

Significantly improved OS through 5 years1

Median OS significantly extended by 4.9 months: 20.9 months median OS with Optune + TMZ vs 16.0 months with TMZ alone (P=0.00006)1,†

160% improvement in survival with Optune + TMZ vs TMZ alone at 5 years1,‡

Significantly improved PFS1

Median time from diagnosis to randomization was 3.7 months1

* Both interim and 5-year survival analyses are protocol prespecified.3
In the interim analysis (n=315), Optune + TMZ extended median OS by 4.9 months (per protocol) and extended PFS by 3.2 months (ITT), and this was consistent with the 5-year survival ITT analysis (n=695).1,4
At the time of the interim analysis, there were too few patients with sufficient follow-up to report results at 5 years.5

In the interim analysis of EF-14, Optune + TMZ significantly extended median OS and median PFS (n=315)4-6,*

Optune + TMZ significantly extended median overall survival by 4.9 months
Optune + TMZ significantly improved median progression-free survival

PFS was assessed by blinded, central MRI review4,6

§ In the 5-year survival ITT analysis (n=695), Optune + TMZ extended median OS by 4.9 months and extended median PFS by 2.7 months, and this was consistent with the interim per protocol and ITT analysis (n=315).1,2,4

QoL was maintained with Optune + TMZ4

Patients' quality of life, cognitive function, and ability to perform activities of daily living did not significantly decline with the use of Optune + TMZ in patients for whom 12 months of QoL data were available

Optune was studied in the EF-14 trial, a prospective, international, multicenter, open-label, randomized, controlled, phase 3 trial in newly diagnosed GBM patients comparing Optune + TMZ with TMZ alone (N=700). The prespecified interim analysis occurred when the first 315 patients completed 18 months of follow-up. The primary endpoint was PFS (ITT); OS (per protocol) was a powered secondary endpoint; 1- and 2-year survival rates, PFS6, QoL, and radiological response rates, along with safety, were also secondary endpoints. The 5-year survival analysis included all 695 patients who completed >24 months of follow-up.1,4,6

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Optune + TMZ—a standard treatment option for newly diagnosed GBM

The updated NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Central Nervous System Cancers now include alternating electric field therapy (Optune) in combination with temozolomide (TMZ) following standard brain radiation therapy with concurrent TMZ as a Category 2A recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial glioblastoma (GBM).7

View NCCN Guidelines treatment algorithm

CI, confidence interval; GBM, glioblastoma; HR, hazard ratio; ITT, intent to treat; OS, overall survival; PFS6, progression-free survival at 6 months; QoL, quality of life; TMZ, temozolomide.

References: 1. Stupp R, Hegi ME, Idbaih A, et al. Tumor treating fields added to standard chemotherapy in newly diagnosed glioblastoma (GBM): fInal results of a randomized, multicenter, phase III trial. In: Program and abstracts of the 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Abstract LBA AACR CT007. 2. Stupp R, Hegi ME, Idbaih A, et al. Tumor treating fields added to standard chemotherapy in newly diagnosed glioblastoma (GBM): final results of a randomized, multicenter, phase III trial. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007 3. Novocure Data on File. OPT-102. 4. Optune Instructions For Use. Novocure 2016. 5. Novocure Data on File. OPT-103. 6. Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2535-2543. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.1.2016. ©2016 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed July 25, 2016. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

Quick facts about Optune

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Results published in JAMA

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OPT-055.2-08


Indications For Use

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.

Important Safety Information

Contraindications

Do not use Optune in patients with 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 in patients that 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

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache.

The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer.

Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment.


Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.

Patient Journey videos on this site depict actual patients and caregivers. All other depictions of patients, caregivers and health care professionals are actor portrayals.

Indications For Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).