Table 1:
Baseline characteristics in the intention-to-treat population
| Pembrolizumab 2 mg/kg (n=180) | Pembrolizumab 10 mg/kg (n=181) | Chemotherapy control (n=179) | |
|---|---|---|---|
| Median age (years) | 62 (15–87) | 60 (27–89) | 63 (27–87) |
| Men | 104 (58%) | 109 (60%) | 114 (64%) |
| Women | 76 (42%) | 72 (40%) | 65 (36%) |
| Ethnic origin | |||
| White | 176 (98%) | 179 (99%) | 172 (96%) |
| Other | 4 (2%) | 2 (1%) | 6 (3%) |
| Missing | 0 | 0 | 1 (<1%) |
| ECOG performance status | |||
| 0 | 98 (54%) | 98 (54%) | 99 (55%) |
| 1 | 80 (44%) | 83 (46%) | 80 (45%) |
| Missing | 2 (1%) | 0 | 0 |
| BRAFV600 status | |||
| Mutant | 44 (24%) | 40 (22%) | 41 (23%) |
| Wild type | 136 (76%) | 141 (78%) | 138 (77%) |
| Lactate dehydrogenase concentration | |||
| Normal | 99 (55%) | 105 (58%) | 107 (60%) |
| Raised | 77 (43%) | 73 (40%) | 68 (38%) |
| Unknown | 4 (2%) | 3 (2%) | 4 (2%) |
| Median size of target lesions | 95 (10–428) | 101 (12–560) | 102 (11–568) |
| M staging of extent of metastasis | |||
| M0 | 1 (<1%) | 1 (<1%) | 2 (1%) |
| M1a | 9 (5%) | 13 (7%) | 15 (8%) |
| M1b | 22 (12%) | 17 (9%) | 15 (8%) |
| M1c | 148 (82%) | 150 (83%) | 147 (82%) |
| Number of lines of previous systemic therapies | |||
| 0* | 1 (<1%) | 0 | 0 |
| 1 | 40 (22%) | 56 (31%) | 47 (26%) |
| 2 | 79 (44%) | 66 (36%) | 78 (44%) |
| ≥3 | 60 (33%) | 59 (33%) | 54 (30%) |
| Previous therapy | |||
| Ipilimumab | 180 (100%) | 181 (100%) | 179 (100%) |
| Interleukin 2 | 21 (12%) | 16 (9%) | 12 (7%) |
| Immunotherapy, excluding ipilimumab and interleukin 2 | 25 (14%) | 18 (10%) | 23 (13%) |
| Chemotherapy | 90 (50%) | 84 (46%) | 86 (48%) |
| BRAF or MEK inhibitor | 46 (26%) | 45 (25%) | 43 (24%) |
Data are median (range) or n (%). ECOG=Eastern Cooperative Oncology Group.
*
Patients with no previous systemic therapies received neoadjuvant or adjuvant therapy only.