Table 2.
Efficacy outcomes in mITT population
| Arm B (N = 24) |
Arm C (N = 13) |
Arm D (N = 30) |
|
|---|---|---|---|
| 6-month PFS* %, (95% CI) | 10.0 (2.7 - 35.4) | 7.7 (1.2 - 50.6) | 17.2 (7.8 - 38.3) |
| Progression Free at 6 Months, n (%) | 2 (8.3) | 1 (7.7) | 5 (16.7) |
| Median PFS, months (95% CI) | 1.6 (1.2- 3.2) | 1.9 (1.8- 14.9) | 1.9 (1.8- 3.0) |
| Median OS, months (95% CI) | 10.5 (4.9 - 17.0) | 8.5 (7.3 - NE) | 10.2 (7.0 - 15.4) |
| Best Overall Response, n (%) | 2 (8.3) | 1 (7.7) | 3 (10.0) |
| 95% CI | (1.0 - 27.0) | (0.2 - 36.0) | (2.1 - 26.5) |
| Complete Response, n (%) | 0 (0) | 0 (0) | 1 (3.3) |
| 95% CI | NE | NE | (0.1 - 17.2) |
| Partial Response, n (%) | 2 (8.3) | 1 (7.7) | 2 (6.7) |
| 95% CI | (1.0 - 27.0) | (0.2 - 36) | (0.8 - 22.1) |
| Stable Disease, n (%) | 6 (25.0) | 4 (30.8) | 7 (23.3) |
| 95% CI | (9.8 - 46.7) | (9.1 - 61.4) | (9.9 - 42.3) |
| Progressive Disease, n (%) | 15 (62.5) | 8 (61.5) | 17 (56.7) |
| 95% CI | (40.6 - 81.2) | (31.6 - 86.1) | (37.4 - 74.5) |
CI, confidence interval; NE, not evaluable; PFS, progression-free survival; OS, overall survival
*
survival rate point estimates are presented for 6-month PFS using the Kaplan-Meier method. One patient from Arm C who did not undergo efficacy evaluation is not included in the efficacy analyes.