Summary of response to treatment and survival end points by arm based on IRC assessment (N = 84)
| . | 21/28 (N = 43) . | 28/28 (N = 41) . | Total . |
|---|---|---|---|
| Response rate, n (%) | ITT (N = 84) | ||
| ORR (≥PR) | 15 (35) | 14 (34) | 29 (34.5) |
| CR* | 1 (2) | 2 (5) | 3 (4) |
| VGPR | 1 (2) | 1 (2) | 2 (2) |
| PR | 13 (30) | 11 (27) | 24 (27) |
| Stable disease | 19 (44) | 21 (51) | 40 (48) |
| Progressive disease | 5 (12) | 3 (7) | 8 (9.5) |
| Not evaluable | 4 (9) | 3 (7) | 7 (8) |
| Median time to first response (95% CI), months | 2.7 (0.8, 9.5) | 1.1 (0.6, 8) | 1.8 (0.6, 9.5) |
| Median duration of response (95% CI), months | 6.4 (4, —) | 8.3 (6.5, 16) | 7.3 (5, 15) |
| One year free of relapse, % | 42 | 47 | 44 |
| EE (N = 66) | |||
| ORR (CR + PR) | 15 (44) | 12 (37.5) | 27 (41) |
| ≥VGPR | 2 (6) | 3 (9) | 5 (7.5) |
| Median survival (95% CI), months | 21/28 (N = 43) | 28/28 (N = 41) | Total |
| Time to progression | 5.8 (3, 10) | 4.8 (3, 7) | 5.4 (4, 8) |
| At 1 y, % | 31 | 25 | 28 |
| Progression-free survival | 5.4 (3, 9) | 3.7 (2, 7) | 4.6 (4, 7) |
| At 1 y, % | 29 | 22 | 25.5 |
| Overall survival | 14.9 (9, —) | 14.8 (9, 20) | 14.9 (11, 20) |
| At 12 mo, % | 58 | 56 | 57 |
| At 18 mo, % | 49 | 39 | 44 |
| . | 21/28 (N = 43) . | 28/28 (N = 41) . | Total . |
|---|---|---|---|
| Response rate, n (%) | ITT (N = 84) | ||
| ORR (≥PR) | 15 (35) | 14 (34) | 29 (34.5) |
| CR* | 1 (2) | 2 (5) | 3 (4) |
| VGPR | 1 (2) | 1 (2) | 2 (2) |
| PR | 13 (30) | 11 (27) | 24 (27) |
| Stable disease | 19 (44) | 21 (51) | 40 (48) |
| Progressive disease | 5 (12) | 3 (7) | 8 (9.5) |
| Not evaluable | 4 (9) | 3 (7) | 7 (8) |
| Median time to first response (95% CI), months | 2.7 (0.8, 9.5) | 1.1 (0.6, 8) | 1.8 (0.6, 9.5) |
| Median duration of response (95% CI), months | 6.4 (4, —) | 8.3 (6.5, 16) | 7.3 (5, 15) |
| One year free of relapse, % | 42 | 47 | 44 |
| EE (N = 66) | |||
| ORR (CR + PR) | 15 (44) | 12 (37.5) | 27 (41) |
| ≥VGPR | 2 (6) | 3 (9) | 5 (7.5) |
| Median survival (95% CI), months | 21/28 (N = 43) | 28/28 (N = 41) | Total |
| Time to progression | 5.8 (3, 10) | 4.8 (3, 7) | 5.4 (4, 8) |
| At 1 y, % | 31 | 25 | 28 |
| Progression-free survival | 5.4 (3, 9) | 3.7 (2, 7) | 4.6 (4, 7) |
| At 1 y, % | 29 | 22 | 25.5 |
| Overall survival | 14.9 (9, —) | 14.8 (9, 20) | 14.9 (11, 20) |
| At 12 mo, % | 58 | 56 | 57 |
| At 18 mo, % | 49 | 39 | 44 |
CR confirmed by bone marrow assessment.