Figure 1
Figure 2
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Figure 4
Demographic and disease characteristics of the patients
| Median age (range) – years | 65.4 (25-87) |
| Older than 70 years – n (%) | 47 (48.9%) |
| Male gender –n (%) | 84 (60.9) |
| Average body weight (range) – kilograms | 79.5 (46 – 138) |
| ECOG performance status –n (%) | |
| 0 | 53 (38.4) |
| 1 | 71 (51.4) |
| 2 | 12 (8.7) |
| 3 | 2 (1.4) |
| Anatomic site of primary | |
| Cutaneous | 116 (84.1) |
| Ocular | 8 (5.8) |
| Mucosal | 7 (5.1) |
| Unknown primary | 7 (5.1) |
| Actionable mutation –n (%) | |
| Wild type | 94 (68.1) |
| BRAF V600E | 22 (15.9) |
| BRAF V600K/M | 3 (2.2) |
| NRAS | 3 (2.2) |
| Not provided | 16 (11.6) |
| Elevated baseline LDH level (> 4.31 microkat/L) – n (%) | 36 (26.1) |
| Elevated baseline S100 level (> 0.105 microg/L) – n (%) | 72 (52.2) |
| Metastatic stage – n (%)* | |
| M1a (0) | 28 (20.3) |
| M1a (1) | 6 (4.3) |
| M1b (0) | 29 (21.0) |
| M1b (1) | 2 (1.4) |
| M1c (0) | 32 (23.2) |
| M1c (1) | 22 (15.9) |
| M1d (0) | 13 (9.4) |
| M1d (1) | 6 (4.3) |
| Organs with metastatic involvement –n (%) | |
| 1 | 47 (34.1) |
| 2 | 52 (37.7) |
| 3 | 19 (13.8) |
| >3 | 20 (14.5) |
| Further lines of systemic therapy – n (%) | 41 (29.7) |
| Radiotherapy during immunotherapy –n (%) | 38 (27.5) |
Immune related adverse events
| Adverse event* | Any grade – no. (%) | Grade 3-4 – no. (%) |
|---|---|---|
| Any | 88 (63.8) | 12 (8.7) |
| High AST, ALT | 35 (25.4) | 3 (2.2) |
| Hypothyroidism | 33 (23.9) | 0 |
| Pruritus | 28 (20.3) | 0 |
| Rash | 25 (18.1) | 1 (0.7) |
| Arthralgia | 14 (10) | 2 (1.4) |
| Diarrhoea | 13 (9.4) | 1 (0.7) |
| Fatigue | 8 (5.8) | 0 |
| Pneumonitis | 7 (5.1) | 2 (1.4) |
| Vitiligo | 7 (5.1) | 0 |
| Other | 12 (8.7) | 4 (2.9) |
Best overall responses and median overall survival for each group
| Response | n (%) |
|---|---|
| ORR | 60 (43.5) |
| DCR | 83 (60.2) |
| Best response | |
| CR | 29 (21.0) |
| PR | 31 (22.5) |
| SD | 23 (16.7) |
| PD | 54 (39.1) |
| No assessment | 1 (0.7) |