Treatment for glioblastoma (GBM)
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Optune® Novocure™

Recurrent GBM study design

EF-11 phase 3 pivotal trial—Optune vs physician's choice of chemotherapy, including bevacizumab

EF-11 phase 3 pivotal trial: Optune® vs chemotherapy, including bevacizumab

*Therapy options were the physician's best choice for chemotherapy, including bevacizumab, which were defined given historical assessment of effective recurrent GBM therapies. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.
  • NovoTAL™ System utilized to create individualized treatment maps for all patients receiving Optune

  • Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen

Key efficacy endpoints

  • Primary endpoint

    • OS

  • Secondary endpoints

    • 1-year survival

    • PFS6

    • Median time to progression

    • Radiological response rates

    • QoL

How Optune works

See how Tumor Treating Fields (TTFields) disrupt mitosis and inhibit tumor growth.

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Quick facts about Optune

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Key inclusion criteria

Key exclusion criteria

EF-11: Key Baseline Characteristics

Intent to treat (ITT) population

Characteristics Optune (n=120)
n (%)
Chemotherapy* (n=117)
n (%)
Median age (years) 54 54
Female gender 28 (23) 44 (38)
Median KPS (min, max) 80 (50, 100) 80 (50, 100)
Frontal tumor position 38 (32) 58 (50)
Prior therapy 1st recurrence 11 (9) 17 (15)
2nd recurrence 58 (48) 54 (46)
≥3rd recurrence 51 (43) 46 (39)
Re-operation for recurrence 33 (28) 29 (25)
Prior bevacizumab use 23 (19) 21 (18)
Largest tumor diameter at
randomization, median (range), cm
6.1 (0-15.2) 5.5 (0-16.2)
Median time from diagnosis
to randomization (days)
335 340
*Therapy options were the physician's best choice for chemotherapy, including bevacizumab, which were defined given historical assessment of effective recurrent GBM therapies. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.

Single Agent or in Combination Regimens

ChemotherapyHR (95% CI)
Bevacizumab36 (31)
Irinotecan36 (31)
BCNU/CCNU29 (25)
Carboplatin15 (13)
Temozolomide13 (11)
PCV10 (9)
*Therapy options were the physician’s best choice for chemotherapy, including bevacizumab, which were defined given historical assessment of effective recurrent GBM therapies. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.



CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky performance status; MRI, magnetic resonance imaging; OS, overall survival; PFS6, progression-free survival at 6 months; QoL, quality of life;


References: 1.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. 2. Nabors LB, Ammirati M, Bierman PJ, et al. National Comprehensive Cancer Network. Central nervous system cancers: clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2013; 11(9):1114-1151.


How Optune works

See how Tumor Treating Fields (TTFields) disrupt mitosis and inhibit tumor growth.

Watch video

Quick facts about Optune

Find out more about Optune and how to start patients on therapy.

View now

OPT-055.3-04


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.

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Indications For Use

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