Response rates and MRD-negativity rates according to the relapse subgroup
| . | Early relapse (<24 mos) . | Late relapse (≥24 mos) . | ||||
|---|---|---|---|---|---|---|
| DARA . | Control . | P . | DARA . | Control . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 121 | 110 | 145 | 141 | ||
| ORR | 110 (90.9) | 81 (73.6) | .0004† | 136 (93.8) | 114 (80.9) | .0010‡ |
| ≥CR | 56 (46.3) | 15 (13.6) | <.0001† | 83 (57.2) | 42 (29.8) | <.0001† |
| sCR | 20 (16.5) | 2 (1.8) | 44 (30.3) | 21 (14.9) | ||
| CR | 36 (29.8) | 13 (11.8) | 39 (26.9) | 21 (14.9) | ||
| ≥VGPR | 94 (77.7) | 43 (39.1) | <.0001† | 114 (78.6) | 83 (58.9) | .0003† |
| VGPR | 38 (31.4) | 28 (25.5) | 31 (21.4) | 41 (29.1) | ||
| PR | 16 (13.2) | 38 (34.5) | 22 (15.2) | 31 (22.0) | ||
| MR | 3 (2.5) | 10 (9.1) | 2 (1.4) | 7 (5.0) | ||
| SD | 4 (3.3) | 15 (13.6) | 6 (4.1) | 18 (12.8) | ||
| PD | 4 (3.3) | 3 (2.7) | 0 | 2 (1.4) | ||
| NE | 0 | 1 (0.9) | 1 (0.7) | 0 | ||
| MRD (10−5)‡ | ||||||
| Patients evaluated, n | 125 | 115 | 146 | 144 | ||
| MRD negative, n (%) | 28 (22.4) | 3 (2.6) | <.0001§ | 46 (31.5) | 15 (10.4) | <.0001§ |
| . | Early relapse (<24 mos) . | Late relapse (≥24 mos) . | ||||
|---|---|---|---|---|---|---|
| DARA . | Control . | P . | DARA . | Control . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 121 | 110 | 145 | 141 | ||
| ORR | 110 (90.9) | 81 (73.6) | .0004† | 136 (93.8) | 114 (80.9) | .0010‡ |
| ≥CR | 56 (46.3) | 15 (13.6) | <.0001† | 83 (57.2) | 42 (29.8) | <.0001† |
| sCR | 20 (16.5) | 2 (1.8) | 44 (30.3) | 21 (14.9) | ||
| CR | 36 (29.8) | 13 (11.8) | 39 (26.9) | 21 (14.9) | ||
| ≥VGPR | 94 (77.7) | 43 (39.1) | <.0001† | 114 (78.6) | 83 (58.9) | .0003† |
| VGPR | 38 (31.4) | 28 (25.5) | 31 (21.4) | 41 (29.1) | ||
| PR | 16 (13.2) | 38 (34.5) | 22 (15.2) | 31 (22.0) | ||
| MR | 3 (2.5) | 10 (9.1) | 2 (1.4) | 7 (5.0) | ||
| SD | 4 (3.3) | 15 (13.6) | 6 (4.1) | 18 (12.8) | ||
| PD | 4 (3.3) | 3 (2.7) | 0 | 2 (1.4) | ||
| NE | 0 | 1 (0.9) | 1 (0.7) | 0 | ||
| MRD (10−5)‡ | ||||||
| Patients evaluated, n | 125 | 115 | 146 | 144 | ||
| MRD negative, n (%) | 28 (22.4) | 3 (2.6) | <.0001§ | 46 (31.5) | 15 (10.4) | <.0001§ |
Data shown of the pooled CASTOR and POLLUX data set.
The early-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed <24 months after initiating their first line of therapy; the late-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed ≥24 months after initiating their first line of therapy.
DARA, daratumumab; ITT, intent-to-treat; MR, minimal response; NE, not evaluable; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease.
Response-evaluable population with 1 prior line of therapy. The response-evaluable population was defined as patients with a confirmed diagnosis of MM and measurable disease at the baseline or screening visit who received ≥1 administration of study treatment and had ≥1 postbaseline disease assessment.
P value was calculated using the Cochran-Mantel-Haenszel χ2 test stratified based on study ID.
ITT population with 1 prior line of therapy.
P value was calculated using the Fisher exact test.