Table 2.
Efficacy Results of Nivolumab as a Single Agent for Melanoma.
| Efficacy | Nivolumab (n = 210) | Dacarbazine (n = 208) |
|---|---|---|
| Overall Survival | ||
| Events (%) | 50 (24) | 96 (46) |
| Median, months (95% CI) | Not Reached | 10.8 (9.3, 12.1) |
| Hazard ratio (95% CI) | 0.42 (0.30, 0.60) | |
| p-Value | <0.0001 a | |
| Progression-Free Survival | ||
| Events (%) | 108 (51) | 163 (78) |
| Median, months (95% CI) | 5.1 (3.5, 10.8) | 2.2 (2.1, 2.4) |
| Hazard ratio (95% CI) | 0.43 (0.34, 0.56) | |
| p-Value | <0.0001 a | |
| Objective Response Rate (95% CI) | 34% (28, 41) | 9% (5, 13) |
| Complete response rate | 4% | 1% |
| Partial response rate | 30% | 8% |
a p-Value is compared with the allocated alpha of 0.0021 for this interim analysis.