Table 2.
Investigator-Assessed Confirmed Objective Response
| BRAF Wild-Type | BRAF V600 Mutant | |||
|---|---|---|---|---|
| Nivolumab + Ipilimumab | Ipilimumab | Nivolumab + Ipilimumab | Ipilimumab | |
| All randomized population, N | 72 | 37 | 23 | 10 |
| Best overall response, n (%)a | ||||
| Complete response | 16 (22.2) | 0 | 5 (21.7) | 0 |
| Partial response | 28 (38.9) | 4 (10.8) | 7 (30.4) | 1 (10.0) |
| Stable disease | 9 (12.5) | 13 (35.1) | 3 (13.0) | 1 (10.0) |
| Progressive disease | 10 (13.9) | 15 (40.5) | 5 (21.7) | 7 (70.0) |
| Unable to determine | 9 (12.5) | 5 (13.5) | 3 (13.0) | 1 (10.0) |
| Objective response rateb | ||||
| Number of responders (%) | 44 (61.1) | 4 (10.8) | 12 (52.2) | 1 (10.0) |
| 95% CI | 48.9, 72.4 | 3.0, 25.4 | 30.6, 73.2 | 0.3, 44.5 |
| Estimate odds ratio (95% CI)c | 12.96 (3.91, 54.49) | 9.82 (0.99, 465.39) | ||
| P value for comparison | <0.001 | NE | ||
a
Assessed by investigator using RECIST v1.1.
b
Complete response + partial response; CI based on the Clopper and Pearson method.
c
Ratio of nivolumab + ipilimumab over ipilimumab.
NE denotes not evaluated.