Newly Diagnosed Study Design
In newly diagnosted GBM,
Optune Gio™ + TMZ efficacy was proven in a phase 3 randomized trial of 695 patients1
EF-14 phase 3 pivotal trial—Optune Gio + TMZ vs TMZ alone in newly diagnosed GBM1-3
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 Gio
- Patients were able to stay on Optune Gio through first progression but could switch additional treatment1,2
- Patients were able to stay on Optune Gio 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 Optune Gio2
Efficacy endpoints1,3
- 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 McDonald criteria, following concomitant chemoradiation
- Implanted electronic medical devices
- Significant comorbidities at baseline that would prevent maintenance TMZ treatment
- Infratentorial tumor(s)
Patient characteristics2
Learn how Optune Gio increased survival in patients with recurrent GBM
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; 2023. 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. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. Supplement 1. Trial protocol and statistical analysis plan. JAMA. 2017;318(23):2306-2316. Accessed November 14, 2022. https://jamanetwork.com/journals/jama/fullarticle/2666504