Table 3:
Efficacy outcomes
| Phase I CRT+ Veliparib (n = 21) | Phase II | |||
|---|---|---|---|---|
| CRT+ Veliparib (n = 18) | CRT + Placebo (n = 13) | p-value | ||
| Outcomes from Initial Registration (Start of CRT) | ||||
| Objective Response | n = 18 86% (64%, 97%) | n = 10 56% (31%, 78%) | n = 9 69% (38%, 91%) | 0.69 |
| Disease Control (objective response + stable disease) | n = 18 86% (64%, 97%) | n = 15 83% (59%, 96%) | n = 11 85% (55%, 98%) | 0.56 |
| PFS | ||||
| HR* (95% CI) | N/A | 1.47 (0.59, 3.66) | 0.20 | |
| Median in months (95%CI) | 11.5 (9.5, 19.2) | 9.3 (7.3, 17.4) | 9.9 (5.7, 23.6) | |
| 1-year estimate (95% CI) | 40% (19%, 60%) | 41% (18%, 63%) | 46% (19%, 70%) | |
| Overall Survival | ||||
| HR* (95% CI) | N/A | 0.65 (0.24, 1.75) | 0.19 | |
| Median in months (95% CI) | 32.9 (13.8, 37.8) | 27.6 (17.4, 27.6) | 15.2 (6.6, 20.6) | |
| 1-year estimate | 70% (45%, 85%) | 89% (61%, 97%) | 54% (25%, 76%) | |
| Outcomes from start of Consolidation | N = 14 | N = 13 | N = 10 | |
| PFS | ||||
| HR* (95% CI) | N/A | 1.65 (0.54,5.01) | 0.19 | |
| 1-year estimate (95% CI) | 50% (23%, 72%) | 43% (16%, 68%) | 40% (12%, 67%) | |
| Overall Survival | ||||
| HR* (95% CI) | N/A | 0.71 (0.23, 2.20) | 0.28 | |
| 1-year estimate | 79% (47%, 93%) | 76% (42%, 91%) | 50% (18%, 76%) | |
95% confidence intervals in parenthesis
*
HR, hazard ratio, stratified by stage and histologic subtype
CRT, concurrent chemoradiotherapy; PR, partial response; CR, complete response; SD, stable disease; DCR, disease control rate; PFS, progression-free survival; OS, overall survival; NR, not reached; M, months