Confirmed or unconfirmed best responses to ixazomib by investigator assessment
| Response . | Dose-escalation cohorts (n = 23) . | Expansion cohorts (n = 30*) . | Total (N = 50) . |
|---|---|---|---|
| Best response, n (%) | |||
| CR | 0 | 0 | 0 |
| PR | 2 (9) | 8 (27)† | 9 (18)† |
| VGPR | 1 (4) | 0 | 1 (2) |
| MR | 0 | 1 (3) | 1 (2) |
| SD | 7 (30) | 9 (30) | 15 (30) |
| PD | 14 (61) | 12 (40) | 25 (50) |
| Response rates, n (%) (95% CI) | |||
| CR+VGPR | 1 (4) (<1, 22) | 0 | 1 (2) (<1, 11) |
| ≥PR | 2 (9) (1, 28) | 8 (27) (12, 46) | 9 (18) (9, 31) |
| ≥MR | 2 (9) (1, 28) | 9 (30) (15, 49) | 10 (20) (10, 34) |
| Response . | Dose-escalation cohorts (n = 23) . | Expansion cohorts (n = 30*) . | Total (N = 50) . |
|---|---|---|---|
| Best response, n (%) | |||
| CR | 0 | 0 | 0 |
| PR | 2 (9) | 8 (27)† | 9 (18)† |
| VGPR | 1 (4) | 0 | 1 (2) |
| MR | 0 | 1 (3) | 1 (2) |
| SD | 7 (30) | 9 (30) | 15 (30) |
| PD | 14 (61) | 12 (40) | 25 (50) |
| Response rates, n (%) (95% CI) | |||
| CR+VGPR | 1 (4) (<1, 22) | 0 | 1 (2) (<1, 11) |
| ≥PR | 2 (9) (1, 28) | 8 (27) (12, 46) | 9 (18) (9, 31) |
| ≥MR | 2 (9) (1, 28) | 9 (30) (15, 49) | 10 (20) (10, 34) |
CR, complete response; PD, progressive disease; VPGR, very good partial response.
Includes 3 patients from the MTD dose-escalation cohort.
2 PRs unconfirmed; 1 PR unconfirmed but confirmed as MR. Responses were seen across the expansion cohorts, including 2, 3, 1, and 2 PRs in the relapsed and refractory, bortezomib-relapsed, PI-naive, and prior carfilzomib cohorts, respectively.