Table 3.
Efficacy Outcomes
| Outcome | Part A | Part B | Part C | Part B + Ca |
|---|---|---|---|---|
| Marizomib (N = 30) |
Marizomib + Bevacizumab (N = 36) |
Marizomib + Bevacizumab (N = 41) |
Marizomib ≤0.8 mg/m2 + Bevacizumab (N = 67) |
|
| ORR, n (%) | 1 (3.3) | 16 (44.4) | 9 (22.0) | 23 (34.3) |
| Complete response | 0 (0) | 1 (2.8) | 1 (2.4) | 2 (3.0) |
| Partial response | 1 (3.3) | 15 (41.7) | 8 (19.5) | 21 (31.3) |
| Stable disease | 8 (26.7) | 11 (30.6) | 18 (43.9) | 25 (37.3) |
| Progressive disease | 20 (66.7) | 6 (16.7) | 11 (26.8) | 13 (19.4) |
| Not evaluable | 1 (3.3) | 3 (8.3) | 3 (7.3) | 6 (9.0) |
| Duration of response, median (95% CI) | 9.6 (NA–NA) | 6.6 (3.1–8.8) | 4.7 (3.5–7.6) | 5.2 (3.7–7.6) |
| PFS | ||||
| At 6 months, % | 16 | 34 | 22 | 30 |
| OS | ||||
| Median, months (95% CI) | 11.4 (5.5–13.0) | 9.4 (6.3–12.6) | 8.3 (4.8–10.5) | 9.1 (6.3–10.9) |
| At 9 months, % | 55 | 60 | 41 | 52 |
a Excluding dose-escalated patients.
CI, confidence interval; NA, not available; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.