Table 8.
Phase 2 Filanesib (N=32) |
Phase 2 Filanesib/Dex (N=55) |
|
---|---|---|
Time to response, months | ||
N | 5 | 8 |
Median (min, max) | 4.4 (2.6, 15.9) | 2.9 (0.8, 3.7) |
95% CI | 2.6, 15.9 | 0.8, 3.5 |
Duration of response, months | ||
N | 5 | 8 |
Median (min, max) | 8.6 (1.4, 36.9*) | 4.4 (2.4, 21.4) |
95% CI | 1.4, NR | 2.4, 8.1 |
PFS, months | ||
N | 32 | 55 |
Median (min, max) | 1.6 (0.0*, 39.4*) | 2.8 (0.3, 24.6) |
95% CI | 1.0, 3.3 | 1.0, 4.2 |
TFI, months | ||
N | 32 | 55 |
Median (min, max) | 0.9 (0.0*, 16.1*) | 1.0 (0.0, 2.8*) |
95% CI | 0.8, 1.5 | 0.8, 1.4 |
TNT, months | ||
N | 32 | 55 |
Median (min, max) | 4.1 (0.6, 39.9*) | 6.1 (0.4*, 26.9*) |
95% CI | 2.3, 12.0 | 3.8, 7.4 |
OS, months | ||
N | 32 | 55 |
Median (min, max) | 19.0 (0.6*, 39.9*) | 10.7 (0.4, 28.3*) |
95% CI | 7.8, 23.3 | 5.6, 13.4 |
Time to response and duration of response were calculated using responders only. Other parameters were calculated using the safety population.
Patient ongoing.
Abbreviations: CI = confidence interval; Dex = dexamethasone; max = maximum; min = minimum; N or n = number; NR = not reached; OS = overall survival; PFS = progression-free survival; TFI = treatment-free interval; TNT = time to next treatment