Table 1.
Patient baseline characteristics.
| Characteristic | Cohort 1 37.5 μg GM-CSF N = 20 | Cohort 2 75 μg GM-CSF N = 10 | Combined N = 30 |
|---|---|---|---|
| Median age (range) - years | 69.5 (30–81) | 73.5 (50–87) | 70.5 (30–87) |
| Male sex - no. (%) | 13 (65) | 8 (80) | 21 (70) |
| ECOG performance status - no. (%) | |||
| 0 | 14 (70) | 5 (50) | 19 (63) |
| 1 | 6 (30) | 5 (50) | 11 (37) |
| Elevated LDH – no. (%)a | 7 (37) | 2 (20) | 9 (31) |
| Stage – no. (%) | |||
| IIIB | 1 (5) | 1 (10) | 2 (7) |
| IIIC | 7 (35) | 2 (20) | 9 (30) |
| IV | 12 (60) | 7 (70) | 19 (63) |
| M1a | 3 (15) | 2 (20) | 5 (17) |
| M1b | 3 (15) | 2 (20) | 5 (17) |
| M1c | 5 (25) | 3 (30) | 8 (27) |
| M1d | 1 (5) | 0 | 1 (3) |
| Liver metastasis - no. (%) | 3 (15) | 1 (10) | 4 (13) |
| BRAF V600E status – no. (%)b | |||
| Mutated | 6 (35) | 4 (40) | 10 (37) |
| PD-L1 status – no. (%)c | |||
| Positive (≥ 1%) | 7 (53) | 1 (11) | 8 (36) |
| TMB - no. (%)d | |||
| High (≥ 20 mutations/Mb) | 1 (9) | 2 (33) | 3 (18) |
| Intermediate (6–19 mut/Mb) | 4 (36) | 2 (33) | 6 (35) |
| Low (1–5 mutations/Mb) | 6 (55) | 2 (33) | 8 (47) |
aOne patient did not have baseline LDH registered; the denominator for Cohort 1 is 19, combined 29.
bThree patients had missing BRAF status; the denominator for Cohort 1 is 17, combined 27.
cEight Patients had either no available or non-evaluable samples for PD-L1 testing; the denominator for Cohort 1 is 13, combined 22.
dThirteen patients had either no available or non-evaluable samples for TMB testing; the denominator for Cohort 1 is 11, combined 17.