Baseline patient characteristics and comparison of relapsed and non-relapsed patients
| Characteristic | Value | Relapsed | Non-relapsed | All patients |
| No of patients* | 13 (25) | 39 (75) | 52 (100) | |
| Age at treatment, years | Median (range) | 61 (29–77) | 59 (19–83) | 60 (19–83) |
| Sex | Male | 6 (46.2) | 32 (82.1) | 38 (73.1) |
| Female | 7 (53.8) | 7 (17.9) | 14 (26.9) | |
| Race (Caucasian) | Caucasian | 13 (100) | 39 (100) | 52 (100) |
| BMI (continuous), kg/m2 | Median (range) | 29.21 (19.77–37.88) | 29.21 (19.35–60.29) | 29.21 (19.35–60.29) |
| BMI, kg/m2 † | Underweight | 0 (0) | 0 (0) | 0 (0) |
| Normal | 4 (30.8) | 9 (23.1) | 13 (25) | |
| Overweight | 3 (23.1) | 11 (28.2) | 14 (26.9) | |
| Obese | 6 (46.2) | 19 (48.7) | 25 (48.1) | |
| Melanoma subtype | Superficial spreading | 3 (23.1) | 10 (25.6) | 13 (25) |
| Lentigo maligna | 1 (7.7) | 3 (7.7) | 4 (7.7) | |
| Nodular | 2 (15.4) | 4 (10.3) | 6 (11.5) | |
| Desmoplastic/spindle cell | 1 (7.7) | 1 (2.6) | 2 (3.8) | |
| Unknown | 6 (46.2) | 21 (53.8) | 27 (51.9) | |
| Received prior treatment | Yes | 2 (15.4) | 17 (43.6) | 19 (36.5) |
| No | 11 (84.6) | 22 (56.4) | 33 (63.5) | |
| Prior treatment‡ | Ipilimumab | 1 (50) | 5 (17.2) | 6 (31.6) |
| BRAF±MEK inhibitors | 0 (0) | 6 (20.7) | 6 (31.6) | |
| Chemotherapy | 0 (0) | 5 (17.2) | 5 (26.3) | |
| Interferon/interleukin | 1 (50) | 8 (27.6) | 9 (47.4) | |
| Vaccine/intratumoral injection | 0 (0) | 5 (17.2) | 5 (26.3) | |
| LDH at baseline (U/L) | <1 x ULN | 11 (84.6) | 33 (84.6) | 44 (84.6) |
| >1 x to <2 x ULN | 2 (15.4) | 4 (10.3) | 6 (11.5) | |
| >2 x ULN | 0 (0) | 1 (2.6) | 1 (1.9) | |
| Unknown | 0 (0) | 1 (2.6) | 1 (1.9) | |
| Neutrophil count at treatment | Median (range) | 5.43 (2.3–11.9) | 4 (2.2–7.2) | 4.21 (2.2–11.9) |
| Lymphocyte count at treatment | Median (range) | 1.5 (0.9–2.27) | 1.5 (0.71–3.3) | 1.5 (0.71–3.3) |
| Neutrophil–lymphocyte ratio | Median (range) | 3.33 (1.53–13.22) | 2.54 (1.24–9) | 2.79 (1.24–13.22) |
| Eastern Cooperative Oncology Group Performance status at baseline | 0 | 9 (69.2) | 22 (56.4) | 31 (59.6) |
| 1 | 2 (15.4) | 8 (20.5) | 10 (19.2) | |
| 2 | 1 (7.7) | 4 (10.3) | 5 (9.6) | |
| 3 | 0 (0) | 1 (2.6) | 1 (1.9) | |
| Unknown | 1 (7.7) | 4 (10.3) | 5 (9.6) | |
| Sites of metastatic disease | Brain | 9 (69.2) | 8 (20.5) | 17 (32.7) |
| Bone | 2 (15.4) | 2 (5.1) | 4 (7.7) | |
| Liver | 0 (0) | 9 (23.1) | 9 (17.3) | |
| Lung | 6 (46.2) | 24 (61.5) | 30 (57.7) | |
| Lymph nodes(s) | 3 (23.1) | 11 (28.2) | 14 (26.9) | |
| Other site(s)§ | 0 (0) | 14 (35.9) | 14 (26.9) | |
| None (unresectable) | 0 (0) | 1 (2.6) | 1 (1.9) | |
| Largest tumor size (cm) | <1 | 3 (23.1) | 2 (5.1) | 5 (9.6) |
| >1 to <5 | 8 (61.5) | 23 (60) | 31 (59.6) | |
| >5 to <10 | 0 (0) | 4 (10.3) | 4 (7.7) | |
| >10 to <20 | 0 (0) | 2 (5.1) | 2 (3.8) | |
| Unknown | 2 (15.4) | 8 (20.5) | 10 (19.2) | |
| BRAF mutation status | Wild type | 3 (23.1) | 20 (51.3) | 23 (44.2) |
| Mutant | 8 (61.5) | 17 (43.6) | 25 (48.1) | |
| Unknown | 2 (15.4) | 2 (5.1) | 4 (7.7) | |
| Other mutations | CDKN2A | 3 (23.1) | 8 (20.5) | 11 (21.2) |
| TP53 | 2 (15.4) | 7 (17.9) | 9 (17.3) | |
| NRAS | 1 (7.7) | 5 (12.8) | 6 (11.5) | |
| APC | 1 (7.7) | 3 (7.7) | 4 (7.7) | |
| ERBB4 | 2 (15.4) | 2 (5.1) | 4 (7.7) | |
| IDH1 | 0 (0) | 3 (7.7) | 3 (5.8) | |
| RB1 | 1 (7.7) | 2 (5.1) | 3 (5.8) | |
| EGFR | 0 (0) | 3 (7.7) | 3 (5.8) | |
| TERT | 0 (0) | 2 (5.1) | 2 (3.8) | |
| KDR | 0 (0) | 2 (5.1) | 2 (3.8) | |
| PIK3CA | 0 (0) | 2 (5.1) | 2 (3.8) | |
| KRAS | 0 (0) | 2 (5.1) | 2 (3.8) | |
| PTEN | 1 (7.7) | 1 (2.6) | 2 (3.8) | |
| ATM | 1 (7.7) | 1 (2.6) | 2 (3.8) | |
| PDGFRA | 0 (0) | 1 (2.6) | 1 (1.9) | |
| ERBB2 | 0 (0) | 1 (2.6) | 1 (1.9) | |
| ALK | 0 (0) | 1 (2.6) | 1 (1.9) | |
| CDH1 | 1 (7.7) | 0 (0) | 1 (1.9) | |
| HNF1A | 0 (0) | 1 (2.6) | 1 (1.9) | |
| FBXW7 | 0 (0) | 1 (2.6) | 1 (1.9) | |
| CSF1R | 1 (7.7) | 0 (0) | 1 (1.9) | |
| FGFR1 | 1 (7.7) | 0 (0) | 1 (1.9) | |
| FGFR3 | 0 (0) | 1 (2.6) | 1 (1.9) | |
| MET | 0 (0) | 1 (2.6) | 1 (1.9) | |
| GNAQ | 0 (0) | 1 (2.6) | 1 (1.9) | |
| HRAS | 0 (0) | 1 (2.6) | 1 (1.9) | |
| First-line anti-PD-1 | Pembrolizumab | 13 (100) | 35 (89.7) | 48 (92.3) |
| Nivolumab | 0 (0) | 4 (10.3) | 4 (7.7) | |
| Total number of cycles | Median (range) | 17 (10–20) | 17 (9–19) | 17 (9–20) |
| Duration of treatment, months | Median (range) | 11 (6–13) | 11 (6–13) | 11 (6–13) |
Data are no (%) unless otherwise indicated.
*Per cent is row total, otherwise % is column total.
†Underweight=BMI <18.5 kg/m2; normal weight=BMI 18.5–24.9 kg/m2; overweight=BMI 25.0–29.9 kg/m2; obese=BMI >30 kg/m2.
‡Per cent based on two patients (relapsed) and 17 (non-relapsed) who received prior treatment.
§Patients only counted once if they had one or multiple other sites of metastatic disease.
BMI, body mass index; LDH, lactate dehydrogenase; ULN, upper limit of normal.