What is Optune Gio?

The only FDA-approved treatment for ndGBM since 2015

Optune Gio® is a standard of care that has been incorporated into the treatment approach for

30,000 patients with GBM and counting5

As one of the 3 treatments with a proven survival benefit for patients with ndGBM, Optune Gio holds the same level of significance as radiation and chemotherapy6 – 8

Radiation

TMZ

Optune Gio

NCCN Category 1 Preferred: Recommendations for newly diagnosed GBM

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers include alternating electric fields (Optune Gio) as a Category 1 Preferred regimen, following maximal safe resection if feasible (or else biopsy), and standard radiation therapy with concurrent and adjuvant TMZ, for patients aged ≤70 years with newly diagnosed supratentorial GBM and good performance status regardless of MGMT promoter status.9* 

 

Category 1: Based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate. Preferred intervention: Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.9

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 30, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.

Empowering patients in everyday life

What is Optune Gio?

Optune Gio is a noninvasive, wearable medical device that delivers alternating electrical fields (Tumor Treating Fields) as a treatment for patients with GBM. The device essentially consists of a portable generator with its battery and adhesive arrays that are placed on the skin of the head over the tumor site.1

  • Small and lightweight, at just 2.7 pounds10
  • Designed for convenience, carrying comfort, and usability1
  • Wearable and portable for use during most normal daily activities1
Woman gazes at her vanity reflection while using Optune Gio.

Actor portrayal.

Flexible and lightweight design

The polymer-based arrays are designed for comfort and optimal adherence, offering patients a powerful option to fight their disease while they sleep or as they go about their daily routines11†

Portable hands-free freedom

The wearable design of the carrying bag gives patients the flexibility to perform tasks around the house, take walks, or engage in hobbies1,10,12†

Discreet and concealable

The arrays can be discreetly worn under clothing (breathable wigs and scarves), allowing patients to go about their lives without feeling self-conscious

Battery powered and rechargeable

With rechargeable batteries that last up to 3 hours, patients can stay active without needing constant access to a power source. Battery life supports several hours of use, and convenient battery replacements are available to ensure uninterrupted therapy12 

  • “No-Stop Swap” enables patients to swap batteries or power source without disrupting delivery of TTFields

Continuous treatment for continuous results†

Optune Gio delivers TTFields continuously, helping patients maximize their time on treatment without daily interruptions1,12

  • The device provides a steady, targeted approach to managing GBM
  • Patients can choose when to wear and “bank hours” as long as they average 75% of a month using the device

What are TTFields?

Tumor Treating Fields are alternating electrical fields at low intensity (1-3 V/cm) and intermediate frequency (100-300 kHz) specifically tuned to disrupt biological cell processes, disrupting cell division and growth of cancer cells. This type of therapy targets rapidly dividing cells while sparing healthy cells.1

The Optune Gio System

Optune Gio system components are delivered to your patient as part of the Optune Gio treatment kit.

Optune Gio device components labeled by letters.
Letters accompanied by text to explain each of the Optune Gio device components.

*The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial on which the IFU (Instructions for Use) is based used an eligibility criteria of KPS ≥70.3,9

 

†Continuous treatment requires patient to be wearing the powered device. Make sure your patients consult you before physical activity.

 

GBM, glioblastoma; TTFields, Tumor Treating Fields; MGMT, O-6-methylguanine-DNA methyltransferase; NCCN, National Comprehensive Cancer Network®; ndGBM, newly diagnosed glioblastoma; TMZ, temozolomide.

Indications For Use

Optune Gio® 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 Gio® Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

 

References

1. Optune Gio. Instructions For Use. Novocure; 2023. 2. Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields on health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized clinical trial. JAMA Oncol. 2018;4(4):495-504. doi:10.1001/jamaoncol.2017.5082 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. JAMA. 2017;318(23):2306-2316. doi:10.1001/ jama.2017.18718 4. Novocure Data on File US-DOF-0035. 5. Novocure Data on File US-DOF-0038. 6. 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. 7. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996. doi:10.1056/NEJMoa043330 8. Sulman EP, Ismaila N, Armstrong TS, et al. Radiation therapy for glioblastoma: American Society of Clinical Oncology Clinical Practice Guideline endorsement of the American Society for Radiation Oncology Guideline. J Clin Oncol. 2017;35(3):361-369. doi:10.1200/JCO.2016.70.7562 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed November 27, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. 10. Kinzel A, Ambrogi M, Varshaver M, Kirson ED. Tumor treating fields for glioblastoma treatment: patient satisfaction and compliance with the second-generation Optune® system. Clin Med Insights Oncol. 2019:13: 1179554918825449. doi:10.1177/1179554918825449 11. Novocure Data on File US-DOF-0049. 12. Optune. Patient Information and Operation Manual for Glioblastoma Multiforme. Novocure; 2023. 13. Karanam NK, Story MD. An overview of potential novel mechanisms of action underlying tumor treating fields-induced cancer cell death and their clinical implications. Int J Radiat Biol. 2021;97(8):1044-1054. doi:10.1080/09553002.2020.1837984 14. Ahmad MA, Al Natour Z, Mustafa F, Rizvi TA. Electrical characterization of normal and cancer cells. IEEE Access. 2018;6:25979-25986. doi:10.1109/ACCESS.2018.2830883 15. Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295. doi:10.1158/0008-5472.can-04-0083 16. Gera N, Yang A, Holtzman TS, Lee SX, Wong ET, Swanson KD. Tumor treating fields perturb the localization of septins and cause aberrant mitotic exit. PLoS One. 2015;10(5):e0125269. doi:10.1371/journal.pone.0125269 17. Giladi M, Schneiderman RS, Voloshin T, et al. Mitotic spindle disruption by alternating electric fields leads to improper chromosome segregation and mitotic catastrophe in cancer cells. Sci Rep. 2015;5:18046. doi:10.1038/srep18046 18. Novocure Data on File US-DOF-0052. 19. Vanderbeek AM, Rahman R, Fell G, et al. The clinical trials landscape for glioblastoma: is it adequate to develop new treatments? Neuro Oncol. 2018;20(8):1034-1043. doi:10.1093/neuonc/noy027 20. 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 January 9, 2025. https://jamanetwork.com/journals/jama/fullarticle/2666504 21. 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. doi:10.1007/s11060-018-03057-z 22. Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and safety of Tumor Treating Fields (TTFields) in elderly patients with newly diagnosed glioblastoma: subgroup analysis of the phase 3 EF-14 clinical trial. Front Oncol. 2021;11:671972. doi:10.3389/fonc.2021.671972 23. Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields and health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized clinical trial. Supplementary online content. JAMA Oncol. 2018;4(4):495-504. Accessed January 9, 2025. https://jamanetwork.com/journals/jamaoncology/fullarticle/2670704 24. EORTC Quality of Life Group. EORTC QLQ-C30, Version 3.0. 1995. European Organisation for Research and Treatment of Cancer, Belgium. https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-QLQ-C30-English.pdf 25. Zhu JJ, Demireva P, Kanner AA, et al. Health-related quality of life, cognitive screening, and functional status in a randomized phase III trial (EF-14) of tumor treating fields with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. J Neurooncol. 2017;135(3):545-552. doi:10.1007/s11060-017-2601-y 26. Novocure Data on File OPT-103. 27. Lacouture ME, Anadkat MJ, Ballo MT, et al. Prevention and management of dermatologic adverse events associated with Tumor Treating Fields in patients with glioblastoma. Front Oncol. 2020;10:1045. doi:10.3389/fonc.2020.01045 28. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012;48(14):2192-2202. doi:10.1016/j.ejca.2012.04.011 29. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Supplementary Table 1. Eur J Cancer. 2012;48(14):2192-2202. Accessed January 10, 2025. https://www.ejcancer.com/article/S0959-8049(12)00352-8/fulltext 30. Wong ET, Lok E, Swanson KD, et al. Response assessment of NovoTTF-100A versus best physician’s choice chemotherapy in recurrent glioblastoma. Cancer Med. 2014;3(3):592-602. doi:10.1002/cam4.210 31. Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Post hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A™ system versus best physician’s choice of chemotherapy. Semin Oncol. 2014;41(suppl 6):S25-S34. doi:10.1053/j. seminoncol.2014.09.008 32. Novocure Data on File OPT-109. 33. Ballo MT, Conlon P, Lavy-Shahaf G, Kinzel A, Vymazal J, Rulseh AM. Association of Tumor Treating Fields (TTFields) therapy with survival in newly diagnosed glioblastoma: a systematic review and meta-analysis. J Neurooncol. 2023;164(1):1-9. doi:10.1007/s11060-023-04348-w 34. Bähr O, Tabatabai G, Fietkau R, Goldbrunner R, Glas M. Tumor Treating Fields therapy in patients with newly diagnosed glioblastoma: long-term survival results from TTFields in Germany in Routine Clinical Care (TIGER) study. Poster presented at: American Society of Clinical Oncology; May 31–June 4, 2024; Chicago, IL. 35. Palmer JD, Chavez G, Furnback W, et al. Health-related quality of life for patients receiving tumor treating fields for glioblastoma. Front Oncol. 2021;11:772261. doi:10.3389/fonc.2021.772261

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US-OPG-00982 v1.0 July 2025

US-OPG-00982 v1.0 July 2025