Recurrent GBM study design
EF-11 phase 3 pivotal trial—Optune vs physician's choice of chemotherapy, including bevacizumab
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 |
Single Agent or in Combination Regimens
| Chemotherapy | HR (95% CI) |
|---|---|
| Bevacizumab | 36 (31) |
| Irinotecan | 36 (31) |
| BCNU/CCNU | 29 (25) |
| Carboplatin | 15 (13) |
| Temozolomide | 13 (11) |
| PCV | 10 (9) |
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.