Table 2.
Patient Demographics and Disease Characteristics at Baseline
| 25 mg BID (n = 8) | 50 mg BID Cont’ (n = 18) | 50 mg BID Int’ (n = 9) | 75 mg Total Daily (n = 7) | 100 mg BIDa (n = 1) | 300 mg BIDa (n = 7) | Total (N = 50) | |
|---|---|---|---|---|---|---|---|
| Age | |||||||
| Median (range), y | 67 (34–81) | 57 (25–78) | 69 (49–77) | 62 (35–81) | 67 (67) | 64 (47–81) | 63 (25–81) |
| ≤ 65 y, n (%) | 3 (37.5) | 14 (77.8) | 2 (22.2) | 4 (57.1) | 0 | 5 (71.4) | 28 (56.0) |
| White, n (%) | 8 (100.0) | 18 (100.0) | 9 (100.0) | 7 (100.0) | 1 (100.0) | 7 (100.0) | 50 (100.0) |
| Men, n (%) | 6 (75.0) | 9 (50.0) | 6 (66.7) | 3 (42.9) | 1 (100.0) | 7 (100.0) | 32 (64.0) |
| ECOG PS, n (%) | |||||||
| 0 | 5 (62.5) | 16 (88.9) | 6 (66.7) | 6 (85.7) | 1 (100.0) | 4 (57.1) | 38 (76.0) |
| 1 | 3 (37.5) | 2 (11.1) | 3 (33.3) | 1 (14.3) | 0 | 3 (42.9) | 12 (24.0) |
| Current staging, n (%) | |||||||
| IIIB | 1 (12.5)b | 0 | 0 | 0 | 0 | 0 | 1 (2.0) |
| IIIC | 0 | 0 | 2 (22.2) | 0 | 0 | 0 | 2 (4.0) |
| IV | 7 (87.5) | 18 (100.0) | 7 (77.8) | 7 (100.0) | 1 (100.0) | 7 (100.0) | 47 (94.0) |
| Current M classification, n (%) | |||||||
| 0 | 0 | 0 | 2 (22.2) | 0 | 0 | 0 | 2 (4.0) |
| 1a | 1 (12.5) | 3 (16.7) | 0 | 2 (28.6) | 0 | 2 (28.6) | 8 (16.0) |
| 1b | 2 (25.0) | 1 (5.6) | 1 (11.1) | 1 (14.3) | 0 | 0 | 5 (10.0) |
| 1c | 5 (62.5) | 14 (77.8) | 6 (66.7) | 4 (57.1) | 1 (100.0) | 5 (71.4) | 35 (70.0) |
| Most common sites of metastases, n (%) | |||||||
| Lymph nodes | 3 (37.5) | 12 (66.7) | 4 (44.4) | 3 (42.9) | 0 | 6 (85.7) | 28 (56.0) |
| Lung | 4 (50.0) | 13 (72.2) | 4 (44.4) | 3 (42.9) | 1 (100.0) | 1 (14.3) | 26 (52.0) |
| Liver | 2 (25.0) | 6 (33.3) | 3 (33.3) | 3 (42.9) | 0 | 1 (14.3) | 15 (30.0) |
| Abdomen | 0 | 3 (16.7) | 3 (33.3) | 0 | 0 | 3 (42.9) | 9 (18.0) |
| Skin | 1 (12.5) | 4 (22.2) | 1 (11.1) | 1 (14.3) | 0 | 2 (28.6) | 9 (18.0) |
| Adrenals | 1 (12.5) | 3 (16.7) | 2 (22.2) | 0 | 1 (100.0) | 0 | 7 (14.0) |
| CNS/brain | 1 (12.5) | 4 (22.2) | 0 | 1 (14.3) | 0 | 0 | 6 (12.0) |
| Chest wall | 0 | 2 (11.1) | 0 | 1 (14.3) | 0 | 2 (28.6) | 5 (10.0) |
| Breast | 0 | 3 (16.7) | 0 | 0 | 0 | 0 | 3 (6.0) |
| Peritoneum | 0 | 0 | 1 (11.1) | 1 (14.3) | 0 | 0 | 2 (4.0) |
| Bone | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 1 (2.0) |
| Pancreas | 0 | 1 (5.6) | 0 | 0 | 0 | 0 | 1 (2.0) |
| Pleura | 0 | 1 (5.6) | 0 | 0 | 0 | 0 | 1 (2.0) |
| Other | 5 (62.5) | 6 (33.3) | 1 (11.1) | 2 (28.6) | 0 | 3 (42.9) | 17 (34.0) |
| BRAF-mutant positive, n (%) | 2 (25.0) | 8 (44.4) | 2 (22.2) | 1 (14.3) | 1 (100.0) | 2 (28.6) | 16 (32.0) |
| Elevated LDH level, n (%) | 2 (25.0) | 3 (16.7) | 3 (33.3) | 2 (28.6) | 0 | 2 (28.6) | 12 (24.0) |
| Prior radiation therapy, n (%) | 4 (50.0) | 8 (44.4) | 2 (22.2) | 3 (42.9) | 0 | 3 (42.9) | 20 (40.0) |
| Prior systemic regimens for advanced or metastatic disease, n (%) | 1 (12.5) | 12 (66.7) | 3 (33.3) | 2 (28.6) | 1 (100.0) | 4 (57.1) | 23 (46.0) |
| Prior systemic therapy for advanced or metastatic disease, n (%) | |||||||
| Immunotherapy | 0 | 6 (33.3) | 3 (33.3) | 1 (14.3) | 0 | 1 (14.3) | 11 (22.0) |
| Immune checkpoint inhibitor | 0 | 3 (16.7) | 2 (22.2) | 1 (14.3) | 0 | 0 | 6 (12.0) |
| Interferon | 0 | 3 (16.7) | 1 (11.1) | 0 | 0 | 1 (14.3) | 5 (10.0) |
| IL-2 | 0 | 1 (5.6) | 1 (11.1) | 0 | 0 | 0 | 2 (4.0) |
| Other | 0 | 1 (5.6) | 1 (11.1) | 0 | 0 | 0 | 2 (4.0) |
| BRAF inhibitor | 0 | 3 (16.7) | 0 | 0 | 0 | 1 (14.3) | 4 (8.0) |
| Chemotherapy | 0 | 2 (11.1) | 0 | 1 (14.3) | 0 | 2 (28.6) | 5 (10.0) |
| Other | 0 | 4 (22.2) | 1 (11.1) | 2 (28.6) | 1 (100.0) | 1 (14.3) | 9 (18.0) |
BID twice daily, CNS central nervous system, cont’ continuous, ECOG PS Eastern Cooperative Oncology Group performance status, IL-2 interleukin 2, int’ intermittent, LDH lactate dehydrogenase
a Epacadostat 100-mg BID and 300-mg BID dose cohorts were not re-explored in this study after protocol amendment to evaluate lower doses of epacadostat
b Patient was incorrectly staged as IIIB by study site; this patient had metastases in the liver and therefore should have been reported as stage IV