TABLE 2.
Patient demographics and disease characteristics at baseline
| Baseline characteristics, No. (%) | Phase 1 | Phase 2 | ||
|---|---|---|---|---|
| Total a (N = 34) | 100 mg Epa b (n = 49) | 300 mg Epa b (n = 93) | Total (N = 142) | |
| Age, median (range), y | 68 (46–84) | 60 (31‒85) | 65 (29‒87) | 64 (29‒87) |
| Age ≥65 y | 22 (64.7) | 17 (34.7) | 49 (52.7) | 66 (46.5) |
| Male | 21 (61.8) | 30 (61.2) | 68 (73.1) | 98 (69.0) |
| Race | ||||
| White | 33 (97.1) | 41 (83.7) | 83 (89.2) | 124 (87.3) |
| Black or African American | 1 (2.9) | 5 (10.2) | 5 (5.4) | 10 (7.0) |
| ECOG PS | ||||
| 0 | 6 (17.6) | 6 (12.2) | 20 (21.5) | 26 (18.3) |
| 1 | 28 (82.4) | 43 (87.8) | 72 (77.4) | 115 (81.0) |
| ≥2 | 0 | 0 | 1 (1.1) | 1 (0.7) |
| Tumor type | ||||
| Pancreatic | 15 (44.1) | 0 | 0 | 0 |
| TNBC | 0 | 13 (26.5) | 0 | 13 (9.2) |
| NSCLC | 10 (29.4) | 9 (18.4) | 28 (30.1) | 37 (26.1) |
| SCCHN | 8 (23.5) | 7 (14.3) | 31 (33.3) | 38 (26.8) |
| Melanoma | 1 (2.9) | 7 (14.3) | 8 (8.6) | 15 (10.6) |
| Gastric | 0 | 9 (18.4) | 0 | 9 (6.3) |
| Bladder | 0 | 4 (8.2) | 26 (28.0) | 30 (21.1) |
| Prior treatments for advanced/metastatic disease | ||||
| 0 | 1 (2.9) | 8 (16.3) | 15 (16.1) | 23 (16.2) |
| 1 | 11 (32.4) | 10 (20.4) | 27 (29.0) | 37 (26.1) |
| ≥2 | 22 (64.7) | 31 (63.3) | 51 (54.8) | 82 (57.7) |
| Prior use of checkpoint inhibitors | ||||
| Yes | 2 (5.9) | 9 (18.4) | 40 (43.0) | 49 (34.5) |
| No | 32 (94.1) | 40 (81.6) | 53 (57.0) | 93 (65.5) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; Epa, epacadostat; NSCLC, non–small cell lung cancer; SCCHN, squamous cell carcinoma of the head and neck; TNBC, triple‐negative breast cancer.
a
Plus durvalumab 3 mg/kg every 2 weeks or 10 mg/kg every 2 weeks.
b
Plus durvalumab 10 mg/kg every 2 weeks.