Table 3.
Efficacy Results of Nivolumab in Combination with Ipilimumab for Melanoma.
| Endpoint | Nivolumab Plus Ipilimumab a (n = 72) | Ipilimumab (n = 37) |
|---|---|---|
| Objective Response Rate (95% CI) | 60% (48, 71) | 11% (3, 25) |
| Difference in ORR (95% CI) | 49 (31, 61) | |
| p-Value | <0.001 | |
| CR (%) | 17% | 0 |
| PR (%) | 43% | 11% |
| Progression-Free Survival | ||
| Number of events | 27 | 23 |
| Median PFS (months) (95% CI) | 8.9 (7.0, NA) | 4.7 (2.8, 5.3) |
| Hazard ratio (95% CI) | 0.40 (0.22, 0.71) | |
| p-Value | <0.002 | |
NA: not available; a Nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg as a single agent every 2 weeks until disease progression or unacceptable toxicity.