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) |
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) |
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) |