Baseline characteristics
| N = 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) |
*These categories are not mutually exclusive or exhaustive