Treatment for glioblastoma (GBM)
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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

*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

Key inclusion criteria

  • 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 criteria

  • 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 arrythmias

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.

Indications For Use

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