Treatment for glioblastoma (GBM)
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Optune® Novocure™

Newly diagnosed GBM study design

EF-14 phase 3 pivotal trial—Optune + TMZ vs TMZ alone in newly diagnosed GBM1,2

EF-14 phase 3 pivotal trial: Optune® + TMZ vs TMZ alone in newly diagnosed GBM
  • Patients were stratified based on extent of resection and MGMT status1-3

  • Patients were able to stay on Optune through progression but could switch chemotherapy1-2

  • Patients remained on therapy for 24 months or until second progression, whichever came first1,2

  • A prespecified interim analysis occurred when the first 315 patients completed 18 months of follow-up1,2

  • NovoTAL™ System utilized to create individualized treatment maps for all patients receiving Optune2

Efficacy endpoints

  • Primary endpoint1,2

    • PFS, assessed centrally (ITT)

  • Powered secondary endpoint1,2

    • OS (per protocol)

  • Additional secondary endpoints1,2

    • PFS6

    • 1- and 2-year survival

    • QoL

    • Radiological response rates

Key inclusion criteria1,2

  • Underwent maximal debulking surgery and radiotherapy concomitant with temozolomide

  • KPS score ≥70

Key exclusion criteria1

  • Progressive disease per Macdonald criteria, following concomitant chemoradiation

  • Implanted electronic medical devices

  • Significant comorbidities at baseline that would prevent maintenance TMZ treatment

  • Infratentorial tumor(s)

Patient Characteristics (interim analysis)1

Characteristics Optune + TMZ (n=437)
n (%)
TMZ alone (n=207)
n (%)
Gender Male 140 (66.67) 67 (63.81)
Female 70 (33.33) 38 (36.19)
Central MGMT Assessment Invalid 24 (11.43) 11 (10.48)
Unknown 58 (27.62) 30 (28.57)
Methylated 49 (23.33) 26 (24.76)
Unmethylated 79 (37.62) 38 (36.19)
Extent of Resection Biopsy 23 (10.95) 11 (10.48)
Gross Total Resection 135 (64.29) 67 (63.81)
Partial Resection 52 (24.76) 27 (25.71)
Area ROW 83 (39.52) 41 (39.05)
USA 127 (60.48) 64 (60.95)
Karnofsky Performance Score Median 90 90
Min, Max 60, 100 70, 100
Age in Years Median 57 58
Min, Max 6 21, 80
No. of Cycles of TMZ Received Median 6 4
Min, Max 1, 26 1, 24
No. of Cycles of Optune Received Median 9 0
Min, Max 1, 58 0, 0
Time of GBM Diagnosis to Randomization (days) Median 115 113
Min, Max 9 (2%) 43, 170

2L, second line; GBM, glioblastoma; ITT, intent to treat; KPS, Karnofsky Performance Scale; MGMT, O-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; ROW, rest of world; SRS, stereotactic radiosurgery; TMZ, temozolomide.

References: 1. Optune Instructions For Use. Novocure 2016. 2. 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. 3. Novocure Data on File. OPT-102.

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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).