Response rates and MRD negativity rates in all patients and key patient subgroups
| Characteristic . | All patients (N = 49) . | t(11;14) (n = 13) . | Non-t(11;14) (n = 36) . | BCL2 gene expression . | Prior therapy . | |||
|---|---|---|---|---|---|---|---|---|
| High (n = 22) . | Low (n = 17) . | PI refractory (n = 28) . | IMiD refractory (n = 35) . | PI and IMiD refractory (n = 22) . | ||||
| ORR (≥PR) | 39 (80) | 12 (92) | 27 (75) | 19 (86) | 11 (65) | 24 (86) | 29 (81) | 18 (82) |
| ≥VGPR | 32 (65) | 11 (85) | 21 (58) | 17 (77) | 8 (47) | 20 (71) | 23 (64) | 15 (68) |
| ≥CR | 20 (41) | 7 (54) | 13 (36) | 9 (41) | 8 (47) | 13 (46) | 15 (42) | 10 (45) |
| Best overall response | ||||||||
| sCR | 7 (14) | 2 (15) | 5 (14) | 2 (9) | 5 (29) | 5 (18) | 6 (17) | 4 (18) |
| CR | 13 (27) | 5 (38) | 8 (22) | 7 (32) | 3 (18) | 8 (29) | 9 (25) | 6 (27) |
| VGPR | 12 (24) | 4 (31) | 8 (22) | 8 (36) | 0 | 7 (25) | 8 (22) | 5 (23) |
| PR | 7 (14) | 1 (8) | 6 (17) | 2 (9) | 3 (18) | 4 (14) | 6 (17) | 3 (14) |
| MR | 1 (2) | 1 (8) | 0 | 0 | 0 | 0 | 1 (3) | 0 |
| SD | 5 (10) | 0 | 5 (14) | 2 (9) | 3 (18) | 2 (7) | 3 (8) | 2 (9) |
| PD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not evaluable | 4 (8) | 0 | 4 (11) | 1 (5) | 3 (18) | 2 (7) | 3 (8) | 2 (9) |
| MRD | ||||||||
| <10−4 | 9 (18) | 4 (31) | 5 (14) | 7 (32) | 2 (12) | 6 (21) | 7 (20) | 5 (23) |
| <10−5 | 6 (12) | 2 (15) | 4 (11) | 4 (18) | 2 (12) | 3 (11) | 4 (11) | 2 (9) |
| <10−6 | 2 (4) | 1 (8) | 1 (3) | 2 (9) | 0 | 1 (4) | 1 (3) | 1 (5) |
| Median DOR (95% CI), mo | 19.7 (13.1-NE) | NR (9.6-NE) | 16.4 (9.2-NE) | 23.8 (19.8-NE) | 16.4 (13.2-NE) | 19.7 (9.2-NE) | 16.4 (9.6-NE) | NR (9.2-NE) |
| Characteristic . | All patients (N = 49) . | t(11;14) (n = 13) . | Non-t(11;14) (n = 36) . | BCL2 gene expression . | Prior therapy . | |||
|---|---|---|---|---|---|---|---|---|
| High (n = 22) . | Low (n = 17) . | PI refractory (n = 28) . | IMiD refractory (n = 35) . | PI and IMiD refractory (n = 22) . | ||||
| ORR (≥PR) | 39 (80) | 12 (92) | 27 (75) | 19 (86) | 11 (65) | 24 (86) | 29 (81) | 18 (82) |
| ≥VGPR | 32 (65) | 11 (85) | 21 (58) | 17 (77) | 8 (47) | 20 (71) | 23 (64) | 15 (68) |
| ≥CR | 20 (41) | 7 (54) | 13 (36) | 9 (41) | 8 (47) | 13 (46) | 15 (42) | 10 (45) |
| Best overall response | ||||||||
| sCR | 7 (14) | 2 (15) | 5 (14) | 2 (9) | 5 (29) | 5 (18) | 6 (17) | 4 (18) |
| CR | 13 (27) | 5 (38) | 8 (22) | 7 (32) | 3 (18) | 8 (29) | 9 (25) | 6 (27) |
| VGPR | 12 (24) | 4 (31) | 8 (22) | 8 (36) | 0 | 7 (25) | 8 (22) | 5 (23) |
| PR | 7 (14) | 1 (8) | 6 (17) | 2 (9) | 3 (18) | 4 (14) | 6 (17) | 3 (14) |
| MR | 1 (2) | 1 (8) | 0 | 0 | 0 | 0 | 1 (3) | 0 |
| SD | 5 (10) | 0 | 5 (14) | 2 (9) | 3 (18) | 2 (7) | 3 (8) | 2 (9) |
| PD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not evaluable | 4 (8) | 0 | 4 (11) | 1 (5) | 3 (18) | 2 (7) | 3 (8) | 2 (9) |
| MRD | ||||||||
| <10−4 | 9 (18) | 4 (31) | 5 (14) | 7 (32) | 2 (12) | 6 (21) | 7 (20) | 5 (23) |
| <10−5 | 6 (12) | 2 (15) | 4 (11) | 4 (18) | 2 (12) | 3 (11) | 4 (11) | 2 (9) |
| <10−6 | 2 (4) | 1 (8) | 1 (3) | 2 (9) | 0 | 1 (4) | 1 (3) | 1 (5) |
| Median DOR (95% CI), mo | 19.7 (13.1-NE) | NR (9.6-NE) | 16.4 (9.2-NE) | 23.8 (19.8-NE) | 16.4 (13.2-NE) | 19.7 (9.2-NE) | 16.4 (9.6-NE) | NR (9.2-NE) |
Data are expressed as the number (percentage of study group), unless otherwise specified.
BCL2, B-cell lymphoma 2 gene; MR, minimal response; NR, not reached; PD, progressive disease; PR, partial response; sCR, stringent CR; SD, stable disease.