OPTUNE® TREATMENT FOR
GLIOBLASTOMA (GBM)
Intended for US healthcare professionals only.

In recurrent GBM,
The efficacy and safety of Optune monotherapy were compared with physician's choice of chemotherapy*


EF-14 phase 3 pivotal trial design: Optune® + TMZ vs TMZ alone in newly diagnosed GBM
*Therapy options were the physician's best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.
  • Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen1

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

Key efficacy endpoints1,2

  • Primary endpoint

    • OS

  • Secondary endpoints

    • PFS

    • 1-year survival

    • PFS6

    • Median time to progression

    • Radiological response rates

    • QoL

Key inclusion criteria1,2

  • Not a candidate for further radiotherapy or additional resection of residual tumor

  • Subjects with disease progression (by Macdonald criteria, ie, >25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment

  • KPS ≥70

Key exclusion criteria1,2

  • Significant comorbidities within 4 weeks prior to enrollment

  • Surgery for recurrence within 4 weeks

  • Infratentorial tumor

  • Prior radiation or chemotherapy in the past 4 weeks

  • Implanted pacemaker, defibrillator, or deep brain stimulator, or documented clinically significant arrhythmias


EF-11: Key baseline characteristics

Intent to treat (ITT) population

*Therapy options were the physician's best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.

Single agent or in combination regimens

Chemotherapy1n (%)
Bevacizumab36 (31)
Irinotecan36 (31)
BCNU/CCNU29 (25)
PCV10 (9)
Temozolomide13 (11)
Procarbazine1 (1)
Carboplatin15 (13)
Etoposide3 (3)
Imatinib2 (2)
Hydroxyurea1 (1)
None received4 (3)
Multiple listings possible, some agents given in combination.
*Therapy options were the physician’s best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on prior treatment exposure.

CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky performance score; 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. Optune Instructions for Use. Novocure 2019.

Indications For Use

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