Table 4.
Median number of drug treatments for the Intention-to-Treat group (Toca FC) and the standard-of-care (SOC) control arm in the Phase 3 trial.
Toca FC prodrug | Standard of Care (SOC) | ||||
---|---|---|---|---|---|
M_TMZ | TMZ | Lomustine | Bevacizumab | ||
Patients | n=197 | n=18 | n=31 | n=66 | n=26 |
Mean Number of Treatment Cycles (SD) | 3.4 (3.36) | 4.7 (3.80) | 4.4 (3.64) | 2.3 (1.68) | 6.2 (5.49) |
Median Number of Treatment Cycles | 2 | 3 | 3 | 2 | 4 |
Min, Max | 1, 21 | 1, 11 | 1, 15 | 1, 7 | 1, 24 |
M_TMZ: Temozolomide at a dose of 50 mg/m2 once daily continuously
TMZ: Temozolomide at an initial dose of 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle, that may be raised to 200 mg/m2 once daily for 5 consecutive days in the following 28-day treatment cycles
Lomustine: single oral dose of 110 mg/m2 repeated every 6 weeks
Bevacizumab: 10 mg/kg by intravenous (IV) infusion every 2 weeks; 1 cycle is defined by 2 courses of bevacizumab