IRC-assessed efficacy outcomes per modified IWWM-6 consensus criteria
| . | Treatment-naïve (n = 5) . | Relapsed/refractory (n = 21) . | Overall (N = 26) . |
|---|---|---|---|
| Best overall response, n (%) | |||
| VGPR | 1 (20) | 6 (29) | 7 (27) |
| PR | 1 (20) | 5 (24) | 6 (23) |
| MR | 2 (40) | 6 (29) | 8 (31) |
| SD | 1 (20) | 3 (14) | 4 (15) |
| PD | 0 | 1 (5) | 1 (4) |
| Response rates, % (95% CI)* | |||
| VGPR or CR rate | 20 (1, 72) | 29 (11, 52) | 27 (12, 48) |
| MRR | 40 (5, 85) | 52 (30, 74) | 50 (30, 70) |
| ORR | 80 (28, 100) | 81 (58, 95) | 81 (61, 93) |
| Duration of overall response, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 88 (60, 97) | 90 (66, 98) |
| 12-mo event-free rate | 50 (6, 85) | 74 (44, 89) | 68 (42, 84) |
| Duration of CR/VGPR, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 100 | 100 |
| 12-mo event-free rate | 0 | 100 | 75 (13, 96) |
| Duration of major response, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 89 (43, 98) | 91 (51, 99) |
| 12-mo event-free rate | 0 | 78 (37, 94) | 62 (28, 84) |
| Progression-free survival, % (95% CI)† | |||
| 12-mo event-free rate | 80 (20, 97) | 71 (46, 86) | 72 (51, 86) |
| 18-mo event-free rate | 60 (13, 88) | 71 (46, 86) | 68 (46, 83) |
| Overall survival, % (95% CI)† | |||
| 12-mo event-free rate | 100 | 95 (71, 99) | 96 (76, 99) |
| 18-mo event-free rate | 80 (20, 97) | 90 (65, 97) | 88 (67, 96) |
| . | Treatment-naïve (n = 5) . | Relapsed/refractory (n = 21) . | Overall (N = 26) . |
|---|---|---|---|
| Best overall response, n (%) | |||
| VGPR | 1 (20) | 6 (29) | 7 (27) |
| PR | 1 (20) | 5 (24) | 6 (23) |
| MR | 2 (40) | 6 (29) | 8 (31) |
| SD | 1 (20) | 3 (14) | 4 (15) |
| PD | 0 | 1 (5) | 1 (4) |
| Response rates, % (95% CI)* | |||
| VGPR or CR rate | 20 (1, 72) | 29 (11, 52) | 27 (12, 48) |
| MRR | 40 (5, 85) | 52 (30, 74) | 50 (30, 70) |
| ORR | 80 (28, 100) | 81 (58, 95) | 81 (61, 93) |
| Duration of overall response, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 88 (60, 97) | 90 (66, 98) |
| 12-mo event-free rate | 50 (6, 85) | 74 (44, 89) | 68 (42, 84) |
| Duration of CR/VGPR, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 100 | 100 |
| 12-mo event-free rate | 0 | 100 | 75 (13, 96) |
| Duration of major response, % (95% CI)† | |||
| 6-mo event-free rate | 100 | 89 (43, 98) | 91 (51, 99) |
| 12-mo event-free rate | 0 | 78 (37, 94) | 62 (28, 84) |
| Progression-free survival, % (95% CI)† | |||
| 12-mo event-free rate | 80 (20, 97) | 71 (46, 86) | 72 (51, 86) |
| 18-mo event-free rate | 60 (13, 88) | 71 (46, 86) | 68 (46, 83) |
| Overall survival, % (95% CI)† | |||
| 12-mo event-free rate | 100 | 95 (71, 99) | 96 (76, 99) |
| 18-mo event-free rate | 80 (20, 97) | 90 (65, 97) | 88 (67, 96) |
Percentages are based on N, the number of randomized patients.
CI, confidence interval; CR, complete response; IRC, independent review committee; MR, minimal response; MRR, major response rate; ORR, overall response rate; PD progressive disease; PR, partial response; R/R, relapsed or refractory; SD, stable disease; VGPR, very good partial response.
*95% CIs estimated using the Clopper-Pearson method.
Event-free rates were estimated by Kaplan-Meier methodology with 95% CIs estimated using Greenwood’s formula.