Table 1 Baseline characteristics
| Â | NÂ =Â 243 |
|---|---|
Median Age (range) – yr. | 48 (14–77) |
Sex – no. (%) | |
  Male | 133 (55) |
  Female | 110 (45) |
Primary Site – no. (%) | |
 Cutaneous | 188 (77) |
  H&N | 34 (14) |
  LE | 38 (16) |
  UE | 29 (12) |
  Breast | 1 (<1) |
  Trunk – anterior/posterior | 74 (30) |
  Unknown | 12 (5) |
 Mucosal | 14 (6) |
  GI - anorectal | 3 (1) |
  Aerodigestive | 3 (1) |
  Urethral | 1 (<1) |
  Vulva | 7 (3) |
 Unknown | 24 (10) |
 Uveal (choroid) | 16 (7) |
 Other (orbit) | 1 (<1) |
Metastatic status prior to HD IL-2 – no. (%) | |
 Skin, subcutaneous, LN (M1a) | 43 (18) |
 Lung (M1b) | 58 (24) |
 Non-lung visceral (M1c non-CNS) | 99 (41) |
 CNS (M1c CNS) | 43 (18) |
LDH – no. (%) | |
 Normal | 106 (44) |
 Abnormal | 137 (56) |
  1xULN-2xULN | 74 (30) |
   > 2xULN | 63 (26) |
Protocol – no. (%) | |
 Standard of care (SOC) | 193 (79) |
 HD IL-2/temozolomide | 30 (12) |
 HD IL-2+/− ziv-aflibercept (HD IL-2 alone) | 20 (8) |
Line of therapy – no. (%) | |
 1st line | 114 (47) |
 2nd line | 83 (34) |
 3rd line or subsequent line | 46 (19) |
Pre-HD IL-2 therapies* – no. (%) | |
 CTLA-4 inhibitor | 20 (8) |
 PD-1 inhibitor | 2 (1) |
 Other immunotherapies (including biochemotherapy) | 73 (30) |
 BRAFi/MEKi target therapy | 3 (1) |
 Other targeted therapy | 13 (5) |
 Chemotherapy | 54 (22) |
Post-progression therapies* – no. (%) | |
 CTLA-4 inhibitor | 29 (12) |
 PD-1 inhibitor | 11 (5) |
 Other immunotherapies (including biochemotherapy) | 29 (12) |
 BRAFi/MEKi target therapy | 12 (5) |
 Other targeted therapy | 5 (2) |
 Chemotherapy | 43 (18) |