Newly Diagnosed Efficacy

In newly diagnosed GBM,

Optune Gio™ + TMZ provided an unprecedented long-term survival benefit 

Survival with Optune Gio + TMZ vs TMZ alone was significantly higher at the 2-year landmark analysis and remained higher at 5 years1,2

Overall survival (5-year survival analysis)1-3

A standard of care proven to provide the best opportunity for greater OS at 5 years vs TMZ alone (13% vs 5%)1,4

Median OS was significantly extended with Optune Gio—by nearly 5 months (P<0.001)1,2

Optune Gio + TMZ also significantly improved PFS vs TMZ alone1,2

  • Median PFS: 6.7 months vs 4.0 months (P<0.001)

More time on Optune Gio predicted increased significant survival benefit5

Median OS by monthly time (hours/day) on Optune Gio*
  • Monthly usage was a predictor of survival benefit, independent of other prognostic factors such as KPS, age, or MGMT methylation status5

*Based on the amount of time Optune Gio was turned on and providing therapy over the course of a month. These data reflect the average patient usage of 
 Optune Gio for the first 6 months of treatment (months 1-6).5

86% of patients received a survival benefit from Optune Gio because they used it more than half the time (n=388/450)5

Learn how Optune Gio increased survival for elderly patients

Elderly patients post hoc analysis

†Approximation, based on percentage of usage.
‡vs TMZ alone.

References: 1. Optune Gio. Instructions For Use. Novocure; 2023. 2. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 3. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.1.2023. © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed October 6, 2023. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. 5. Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473.

Indications For Use

 

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

 

Optune Gio 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 Gio 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 Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

 

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio 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 Gio 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 Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

 

The most common (≥10%) adverse events involving Optune Gio 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 Gio monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.

 

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

 

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

 

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

Novocure Websites

This website is intended for people seeking information on Optune Gio.

On this site, videos and images identified as Optune Gio users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals.

Patient images reflect the health status of the patients at the time each photo or video was taken.

 

External links

Tumortreatingfieldstherapy.com
Optunegio.com
Optunelua.com
Novocuretrials.com

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US-OPG-00197v1.0 November 2023