Table 4.
Cohort | 1A | 2A | 3A | 4A | 1B | 2B | 3B | All treatment groups |
|
N | 3 | 3 | 8 | 3 | 3 | 4 | 3 | 27 | |
Best overall response, n (%) | CR | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.7) |
PR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
SD | 0 | 2 (66.7) | 2 (25.0) | 0 | 1 (33.3) | 2 (50.0) | 3 (100.0) | 10 (37.0) | |
Non-CR/Non- PD* |
1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.7) | |
PD | 2 (66.7) | 0 | 5 (62.5) | 2 (66.7) | 2 (66.7) | 1 (25.0) | 0 | 12 (44.4) | |
Not Evaluable | 0 | 0 | 1 (12.5) | 1 (33.3) | 0 | 1 (25.0) | 0 | 3 (11.1) | |
Disease control rate (CR+PR+SD) |
0.00% | 100.00% | 25.00% | 0 | 33.30% | 50 | 100.00% | 40.70% | |
95% CI (%) | 0.0, 70.8 |
29.2, 100.0 |
3.2, 65.1 |
0.0, 70.8 |
0.8, 90.6 |
6.8, 93.2 |
29.2, 100.0 |
22.4, 61.2 | |
p-value | 0.1000 |
One patient in this cohort had nontarget disease only, and as per protocol was characterized as Non-CR/Non-PD