Table 4.
Treatment response for patients in 2/7 schedule.
| Phase 1b |
Phase 2 300 mg |
Phase 1b + phase 2 300 mg |
Total 210–330 mg |
Total bortezomib- refractory patients 210–330 mg |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 210 mg |
Cohort 2 240 mg |
Cohort 3 270 mg |
Cohort 4 300 mg |
Cohort 5 330 mg |
|||||
| n | 4 | 4 | 6 | 8 | 6 | 18 | 26 | 46 | 28 |
| BOR, n (%) | |||||||||
| sCR | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 2 (4.3) | 0 |
| CR | 0 | 0 | 0 | 0 | 0 | 1 (5.6) | 1 (3.8) | 1 (2.2) | 1 (3.6) |
| nCR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| VGPR | 0 | 0 | 0 | 1 (12.5) | 3 (50.0) | 2 (11.1) | 3 (11.5) | 6 (13.0) | 0 |
| PR | 2 (50.0) | 1 (25.0) | 2 (33.3) | 4 (50.0) | 0 | 9 (50.0) | 13 (50.0) | 18 (39.1) | 12 (42.9) |
| MR | 1 (25.0) | 0 | 0 | 0 | 0 | 1 (5.6) | 1 (3.8) | 2 (4.3) | 1 (3.6) |
| SD | 0 | 3 (75.0) | 2 (33.3) | 1 (12.5) | 2 (33.3) | 2 (11.1) | 3 (11.5) | 10 (21.7) | 10 (35.7) |
| PD | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (5.6) | 1 (3.8) | 2 (4.3) | 2 (7.1) |
| Not evaluable | 1 (25.0) | 0 | 0 | 2 (25.0) | 0 | 2 (11.1) | 4 (15.4) | 5 (10.9) | 2 (7.1) |
| ORR, % (95% CI) | 50.0 (6.8–93.2) | 25.0 (0.6–80.6) | 50.0 (11.8–88.2) | 62.5 (24.5–91.5) | 66.7 (22.3–95.7) | 66.7 (41.0–86.7) | 65.4 (44.3–82.8) | 58.7 (43.2–73.0) | 46.4 (27.5–66.1) |
| DOR, months | |||||||||
| Median (95% CI) | NE (2.8-NE) | 11.5 (NE-NE) | 7.2 (6.0-NE) | 9.7 (6.0-NE) | NE (4.2-NE) | NE (6.8-NE) | 10.1 (7.3-NE) | 10.9 (7.3-NE) | 7.9 (6.0-NE) |
| CBR, % (95% CI) | 75.0 (19.4–99.4) | 25.0 (0.6–80.6) | 50.0 (11.8–88.2) | 62.5 (24.5–91.5) | 66.7 (22.3–95.7) | 72.2 (46.5–90.3) | 69.2 (48.2–85.7) | 63.0 (47.5–76.8) | 50.0 (30.6–69.4) |
BOR, best overall response; CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DOR, duration of response; MR, minimal response; nCR, near CR; NE, not estimable; OPZ, oprozomib; ORR, overall response rate; PD, progressive disease; PR, partial response; sCR, stringent CR; SD, stable disease; VGPR, very good PR.