Table 1.
Response to treatment
| All randomized patients | Patients with BRAF wild-type tumours | Patients with BRAF mutation-positive tumours | ||||
|---|---|---|---|---|---|---|
| Nivolumab and ipilimumab (N=95) |
Ipilimumab (N=47) |
Nivolumab and ipilimumab (N=72) |
Ipilimumab (N=37) |
Nivolumab and ipilimumab (N=23) |
Ipilimumab (N=10) |
|
| Objective response* | 56 (59% [48–69]) | 5 (11% [3–23]) | 44 (61% [49–72]) | 4 (11% [3–25]) | 12 (52% [31–73]) | 1 (10% [0.3–45]) |
| Odds ratio for comparison | 12.2 (4.4–33.7, p<0.0001) | 13.0 (3.9–54.5, p<0.0001) | 9.8 (1.0–465.4) | |||
| Best overall response* | ||||||
| Complete response | 21 (22.1) | 0 | 16 (22.2) | 0 | 5 (21.7) | 0 |
| Partial response | 35 (36.8) | 5 (10.6) | 28 (38.9) | 4 (10.8) | 7 (30.4) | 1 (10.0) |
| Stable disease | 12 (12.6) | 14 (29.8) | 9 (12.5) | 13 (35.1) | 3 (13.0) | 1 (10.0) |
| Progressive disease | 15 (15.8) | 22 (46.8) | 10 (13.9) | 15 (40.5) | 5 (21.7) | 7 (70.0) |
| Unable to determine | 12 (12.6) | 6 (12.8) | 9 (12.5) | 5 (13.5) | 3 (13.0) | 1 (10.0) |
| Duration of response | ||||||
| Ongoing responders n/N (%) | 45/56 (80%) | 4/5 (80%) | 35/44 (80%) | 3/4 (75%) | 10/12 (83%) | 1/1 (100%) |
| Median (95% CI, months) | NR | NR (6.9–NR) | NR (NR–NR) | NR (6.9–NR) | NR (6.1–NR) | NR |
*
Based on original database lock. Data are n (% [95% CI]) or n (%). Percentages may not add to 100% due to rounding.
NR=not reached.