Table 2.
Efficacy summary.
| Efficacy Measure | Ipilimumab 3 mg/kg (n = 40)* | Ipilimumab 10 mg/kg (n = 42)* |
|---|---|---|
| Response, n (%) | ||
| CR | 0 | 1 (2.4) |
| PR | 3 (7.5) | 4 (9.5) |
| SD | 10 (25.0) | 3 (7.1) |
| PD | 19 (47.5) | 24 (57.1) |
| Unknown | 8 (20.0) | 10 (23.8) |
| BORR, % (95% CI) | 7.5 (1.6, 20.4) | 11.9 (4.0, 25.6) |
| DCR, % | 32.5 | 19.0 |
| OS, median, in months | 12.9 | 11.8 |
| 1-year survival rate†, % (95% CI) | 60.9 (41.7, 74.9) | 44.2 (24.1, 64.1) |
| PFS, median (95% CI), in months | 2.63 (2.56, 3.88) | 2.56 (2.50, 2.66) |
| Progressed or died, n (%) | 28 (70.0) | 32 (76.2) |
| Time to response, median (min- max), in months | 2.5 (2.1-5.3) | 2.6 (2.6-3.6) |
*Four patients (10.0%) in the 3 mg/kg group and five (11.9%) in the 10 mg/kg group were censored from the analyses of response-based endpoints (BORR, PFS, DCR, time to response) because of excision or resection of index lesions.
†Estimated.
BORR: best overall response rate; CI: confidence interval; CR: complete response; DCR: disease control rate; OS: overall survival; PD: progressive disease; PFS: progression-free survival; PR: partial response; SD: stable disease.