Table 4.
Objective response rate by IEAC assessment
| Response, n (%) | Phase 2 (n = 41) | Phase 1 + 2 (n = 45) |
|---|---|---|
| Primary analysis | ||
| DCR (CR + PR+ SD) | 16 (39) | 17 (38) |
| ORR (CR + PR) 90% CI | 9 (22)a 12–35 |
10 (22) 13–35 |
| CR | 4 (10) | 4 (9) |
| PR | 5 (12) | 6 (13) |
| SD | 7 (17) | 7 (16) |
| PD/RD | 24 (59) | 26 (58) |
| Not evaluable | 1 (2) | 2 (4) |
| Final analysis | ||
| DCR (CR + PR+ SD) | 16 (39) | 17 (38) |
| ORR (CR + PR) 90% CI | 10 (25)a 14–38 |
11 (24) 14–37 |
| CR | 4 (10) | 4 (9) |
| PR | 6 (15) | 7 (16) |
| SD | 6 (15) | 6 (13) |
| PD/RD | 24 (59) | 26 (58) |
| Not evaluable | 1 (2) | 2 (4) |
CR complete response, DCR disease control rate, IEAC Independent Efficacy Assessment Committee, ORR objective response rate, PD progressive disease, PR partial response, RD relapsed disease, SD stable disease
aUniformly minimum variance unbiased estimator (UMVUE)