Treatment for glioblastoma (GBM)
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In newly diagnosed GBM,

Patients treated with Optune + TMZ could continue Optune past 1st progression

EF-14 phase 3 pivotal trial: Optune® + TMZ vs TMZ alone in newly diagnosed GBM EF-14 phase 3 pivotal trial: Optune® + TMZ vs TMZ alone in newly diagnosed GBM

Stratification and survival analyses

  • Patients were stratified based on extent of resection and MGMT status2
  • A prespecified interim analysis occurred when the first 315 patients completed 18 months of follow-up1,2
  • The final analysis involved all 695 randomized patients, with a median follow-up of 40 months and a minimum follow-up of 24 months2

Treatments with Optune

  • Patients were able to stay on Optune through first progression but could switch additional treatment1,2
  • Patients could stay on Optune after completing TMZ treatment (6-12 cycles), for up to 24 months or until second progression, whichever came first1,2
  • NovoTAL™ System was utilized to create individualized treatment maps for all patients receiving Optune2

Efficacy endpoints1,2

  • Primary endpoint: PFS, assessed centrally
  • Powered secondary endpoint: OS
  • Additional secondary endpoints: PFS6, 1- and 2-year survival, QoL, radiological response rates

Key inclusion criteria1,2

  • Underwent maximal debulking surgery and radiotherapy concomitant with TMZ
  • KPS ≥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 Characteristics2

Optune® Glioblastoma (GBM) Patient Characteristics Chart Optune® Glioblastoma (GBM) Patient Characteristics Chart

2L, second line; GBM, glioblastoma; KPS, Karnofsky Performance Score; MGMT, 0-6-methylguanine—DNA methyltransferase; OS, overall survival; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life; RT, radiation therapy; SRS, stereotactic radiosurgery; TMZ, temozolomide.

References: 1. Optune Instructions For Use. Novocure 2016. 2. 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. 3. Stupp R, Taillibert S, Kanner A, et al. A prospective, multi-center trial of NovoTTF-100A together with temozolomide compared to temozolomide alone in patients with newly diagnosed GBM: therapeutic protocol. JAMA. 2017;318(23 suppl 1):S1­-S213.

Indications For Use

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