TABLE 1.
Patient disposition
| Disposition status, No. (%) | Phase 1 | Phase 2 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3 mg/kg Durva | 10 mg/kg Durva | Total (N = 34) | 10 mg/kg Durva | Total (N = 142) | ||||||
| 25 mg Epa (n = 6) | 25 mg Epa (n = 3) | 50 mg Epa (n = 4) | 75 mg Epa (n = 4) | 100 mg Epa (n = 8) | 300 mg Epa (n = 9) | 100 mg Epa (n = 49) | 300 mg Epa (n = 93) | |||
| Patients who completed 12 mo of combination treatment | 0 | 1 (33.3) | 1 (25.0) | 0 | 1 (12.5) | 2 (22.2) | 5 (14.7) | 4 (8.2) | 8 (8.6) | 12 (8.5) |
| Patients who discontinued combination treatment | 6 (100.0) | 3 (100.0) | 4 (100.0) | 4 (100.0) | 8 (100.0) | 9 (100.0) | 34 (100.0) | 49 (100.0) | 93 (100.0) | 142 (100.0) |
| Primary reason for treatment discontinuation | 6 (100.0) | 1 (33.3) | 2 (50.0) | 4 (100.0) | 4 (50.0) | 6 (66.7) | 23 (67.6) | 41 (83.7) | 69 (74.2) | 110 (77.5) |
| Disease progression adverse event | 0 | 1 (33.3) | 1 (25.0) | 0 | 1 (12.5) | 0 | 3 (8.8) | 1 (2.0) | 10 (10.8) | 11 (7.7) |
| Death | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 1 (2.9) | 0 | 1 (1.1) | 1 (0.7) |
| Consent withdrawn | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.0) | 2 (2.2) | 3 (2.1) |
| Lost to follow‐up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Abbreviations: Durva, durvalumab; Epa, epacadostat.