Newly Diagnosed Study Design

In newly diagnosted GBM,

Optune Gio™ + TMZ efficacy was proven in a phase 3 randomized trial of 695 patients1

EF-14 phase 3 pivotal trial—Optune Gio + TMZ vs TMZ alone in newly diagnosed GBM1-3

Stratification and survival analyses

  • Patients were stratified based on extent of resection and MGMT status2
  • A prespecified interim analysis occurred when the first 315 patients completed 18 months of follow-up1,2
    • The final analysis involved all 695 randomized patients, with a median follow-up of 40 months and a minimum follow-up of 24 months2

Treatments with Optune Gio

  • Patients were able to stay on Optune Gio through first progression but could switch additional treatment1,2
  • Patients were able to stay on Optune Gio after completing TMZ treatment (6-12 cycles) for up to 24 months or until second progression, whichever came first1,2
  • NovoTAL™ System was utilized to create individualized treatment maps for all patients receiving Optune Gio2

Efficacy endpoints1,3

  • Primary endpoint: PFS, assessed centrally
  • Powered secondary endpoint: OS
  • Additional secondary endpoints: PFS6, 1- and 2-year survival, QoL, radiological response rates

Key inclusion criteria1,2

  • Underwent maximal debulking surgery and radiotherapy concomitant with TMZ
  • KPS ≥70

Key exclusion criteria1

  • Progressive disease per McDonald criteria, following concomitant chemoradiation
  • Implanted electronic medical devices
  • Significant comorbidities at baseline that would prevent maintenance TMZ treatment
  • Infratentorial tumor(s)

Patient characteristics2

Learn how Optune Gio increased survival in patients with recurrent GBM 

Recurrent GBM efficacy

2L, second line; GBM, glioblastoma; KPS, Karnofsky Performance Score; MGMT, 0-6-methylguanine-DNA methyltransferase; OS, overall survival; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life; RT, radiation therapy; SRS, stereotactic radiosurgery; TMZ, temozolomide. 

References: 1. Optune. 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, 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. Supplement 1. Trial protocol and statistical analysis plan. JAMA. 2017;318(23):2306-2316. Accessed November 14, 2022. https://jamanetwork.com/journals/jama/fullarticle/2666504

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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Optune, Optune Gio, MyNovocure, NovoTAL, and Novocure are trademarks of Novocure GmbH. 

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US-OPG-00197v1.0 November 2023