Clinical activity
Part II | Part III N=12 | Pooled Part II and III | |
N=10 (Efficacy population) | N=22 (Efficacy population) | ||
Response rate | N (%) | N (%) | N (%) |
Complete response | 1 (10) | 0 | 1 (4.5) |
Partial response | 4 (40) | 6 (50) | 10 (46) |
Stable disease (SD) | 5 (50) | 6 (42) | 10 (46) |
Overall response rate (ORR) | 5 (50) | 6 (50) | 11 (50) |
Long duration SD* | 5 (50) | 3 (25) | 8 (36.4)* |
ORR at 3.3×1012 | 3 (50) | 1 (17) | 4 (33.3) |
ORR at 1.0×1013 | 2 (50) | 5 (83) | 7 (70) |
Survival analyses | Median in months (95% CI) | Median in months (95% CI) | Median in months (95% CI) |
Progression-free survival (PFS) | 9.94 (2.83 to 19.85) | 6.69 (1.6 to 14.4) | 7.22 (1.6 to 19.85) |
Overall survival | 11.0 (5.03 to 48.43) | 13.47 (2.6 to 29.6+) | 13.35 (2.6 to 48.43) |
*(>1 year).