Response rates and MRD-negativity rates according to the relapse subgroup in CASTOR and POLLUX
| . | CASTOR . | |||||
|---|---|---|---|---|---|---|
| Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
| D-Vd . | Vd . | P . | D-Vd . | Vd . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 47 | 36 | 72 | 73 | ||
| ORR | 39 (83.0) | 26 (72.2) | .2415† | 70 (97.2) | 55 (75.3) | .0001† |
| ≥CR | 13 (27.7) | 4 (11.1) | .0657† | 39 (54.2) | 12 (16.4) | <.0001† |
| sCR | 2 (4.3) | 0 | 16 (22.2) | 5 (6.8) | ||
| CR | 11 (23.4) | 4 (11.1) | 23 (31.9) | 7 (9.6) | ||
| ≥VGPR | 31 (66.0) | 12 (33.3) | .0034† | 60 (83.3) | 34 (46.6) | <.0001† |
| VGPR | 18 (38.3) | 8 (22.2) | 21 (29.2) | 22 (30.1) | ||
| PR | 8 (17.0) | 14 (38.9) | 10 (13.9) | 21 (28.8) | ||
| MR | 2 (4.3) | 2 (5.6) | 1 (1.4) | 6 (8.2) | ||
| SD | 2 (4.3) | 7 (19.4) | 1 (1.4) | 10 (13.7) | ||
| PD | 4 (8.5) | 1 (2.8) | 0 | 2 (2.7) | ||
| NE | 0 | 0 | 0 | 0 | ||
| MRD (10–5)‡ | ||||||
| Patients evaluated, n | 50 | 38 | 72 | 75 | ||
| MRD-negative, n (%) | 5 (10.0) | 0 | .0669§ | 20 (27.8) | 3 (4.0) | <.0001§ |
| . | CASTOR . | |||||
|---|---|---|---|---|---|---|
| Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
| D-Vd . | Vd . | P . | D-Vd . | Vd . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 47 | 36 | 72 | 73 | ||
| ORR | 39 (83.0) | 26 (72.2) | .2415† | 70 (97.2) | 55 (75.3) | .0001† |
| ≥CR | 13 (27.7) | 4 (11.1) | .0657† | 39 (54.2) | 12 (16.4) | <.0001† |
| sCR | 2 (4.3) | 0 | 16 (22.2) | 5 (6.8) | ||
| CR | 11 (23.4) | 4 (11.1) | 23 (31.9) | 7 (9.6) | ||
| ≥VGPR | 31 (66.0) | 12 (33.3) | .0034† | 60 (83.3) | 34 (46.6) | <.0001† |
| VGPR | 18 (38.3) | 8 (22.2) | 21 (29.2) | 22 (30.1) | ||
| PR | 8 (17.0) | 14 (38.9) | 10 (13.9) | 21 (28.8) | ||
| MR | 2 (4.3) | 2 (5.6) | 1 (1.4) | 6 (8.2) | ||
| SD | 2 (4.3) | 7 (19.4) | 1 (1.4) | 10 (13.7) | ||
| PD | 4 (8.5) | 1 (2.8) | 0 | 2 (2.7) | ||
| NE | 0 | 0 | 0 | 0 | ||
| MRD (10–5)‡ | ||||||
| Patients evaluated, n | 50 | 38 | 72 | 75 | ||
| MRD-negative, n (%) | 5 (10.0) | 0 | .0669§ | 20 (27.8) | 3 (4.0) | <.0001§ |
| . | POLLUX . | |||||
|---|---|---|---|---|---|---|
| Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
| D-Rd . | Rd . | P . | D-Rd . | Rd . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 74 | 74 | 73 | 68 | ||
| ORR | 71 (95.9) | 55 (74.3) | .0002† | 66 (90.4) | 59 (86.8) | .4967† |
| ≥CR | 43 (58.1) | 11 (14.9) | <.0001† | 44 (60.3) | 30 (44.1) | .0558† |
| sCR | 18 (24.3) | 2 (2.7) | 28 (38.4) | 16 (23.5) | ||
| CR | 25 (33.8) | 9 (12.2) | 16 (21.9) | 14 (20.6) | ||
| ≥VGPR | 63 (85.1) | 31 (41.9) | <.0001† | 54 (74.0) | 49 (72.1) | .7987† |
| VGPR | 20 (27.0) | 20 (27.0) | 10 (13.7) | 19 (27.9) | ||
| PR | 8 (10.8) | 24 (32.4) | 12 (16.4) | 10 (14.7) | ||
| MR | 1 (1.4) | 8 (10.8) | 1 (1.4) | 1 (1.5) | ||
| SD | 2 (2.7) | 8 (10.8) | 5 (6.8) | 8 (11.8) | ||
| PD | 0 | 2 (2.7) | 0 | 0 | ||
| NE | 0 | 1 (1.4) | 1 (1.4) | 0 | ||
| MRD (10–5)‡ | ||||||
| Patients evaluated, n | 75 | 77 | 74 | 69 | ||
| MRD-negative, n (%) | 23 (30.7) | 3 (3.9) | <.0001§ | 26 (35.1) | 12 (17.4) | .0225§ |
| . | POLLUX . | |||||
|---|---|---|---|---|---|---|
| Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
| D-Rd . | Rd . | P . | D-Rd . | Rd . | P . | |
| Response, n (%)∗ | ||||||
| Patients evaluated, n | 74 | 74 | 73 | 68 | ||
| ORR | 71 (95.9) | 55 (74.3) | .0002† | 66 (90.4) | 59 (86.8) | .4967† |
| ≥CR | 43 (58.1) | 11 (14.9) | <.0001† | 44 (60.3) | 30 (44.1) | .0558† |
| sCR | 18 (24.3) | 2 (2.7) | 28 (38.4) | 16 (23.5) | ||
| CR | 25 (33.8) | 9 (12.2) | 16 (21.9) | 14 (20.6) | ||
| ≥VGPR | 63 (85.1) | 31 (41.9) | <.0001† | 54 (74.0) | 49 (72.1) | .7987† |
| VGPR | 20 (27.0) | 20 (27.0) | 10 (13.7) | 19 (27.9) | ||
| PR | 8 (10.8) | 24 (32.4) | 12 (16.4) | 10 (14.7) | ||
| MR | 1 (1.4) | 8 (10.8) | 1 (1.4) | 1 (1.5) | ||
| SD | 2 (2.7) | 8 (10.8) | 5 (6.8) | 8 (11.8) | ||
| PD | 0 | 2 (2.7) | 0 | 0 | ||
| NE | 0 | 1 (1.4) | 1 (1.4) | 0 | ||
| MRD (10–5)‡ | ||||||
| Patients evaluated, n | 75 | 77 | 74 | 69 | ||
| MRD-negative, n (%) | 23 (30.7) | 3 (3.9) | <.0001§ | 26 (35.1) | 12 (17.4) | .0225§ |
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.
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.
ITT population with 1 prior line of therapy.
P value was calculated using the Fisher exact test.