Frontline phase 3 studies with CD38 antibody-based treatment
| . | MAIA . | ALCYONE . | CASSIOPEIA . | GRIFFIN . | ||||
|---|---|---|---|---|---|---|---|---|
| Regimen | Dara-Rd | Rd | Dara-VMP | VMP | Dara-VTd | VTd | Dara-VRd | VRd |
| HDM | HDM | HDM | HDM | |||||
| Dara-VTd | VTD | Dara-VRd | VRd | |||||
| R2: observation or dara maintenance (2 y) | R2: observation or dara maintenance (2 y) | Dara + len maintenance (Dara 2 y) | len maintenance | |||||
| No. of patients | 368 | 369 | 350 | 356 | 543 | 542 | 104 | 103 |
| Patient population | NDMM, ineligible for transplant | NDMM, ineligible for transplant | NDMM, eligible for transplant | NDMM, eligible for transplant | ||||
| ECOG PS 0-2 | ECOG PS 0-2 | ECOG PS 0-2 | ECOG PS 0-2 | |||||
| Creatinine clearance: ≥30 mL/min | Creatinine clearance: ≥40 mL/min | Creatinine clearance: ≥40 mL/min | Creatinine clearance: ≥30 mL/min | |||||
| Median follow-up, mo | 28 | 40.1 | 18.8 | 22.1 | ||||
| ≥PR | 92.9 | 81.3 | 90.9 | 73.9 | 92.6* | 89.9* | 99.0* | 91.8* |
| (s)CR | 47.6 | 24.9 | 46 | 25 | 39* | 26* | 51.5* | 42.3* |
| MRD negativity (10−5) | 24.2 | 7.3 | 28 | 7 | 64 | 44* | 51.0 | 20.4 |
| HR PFS (95% CI) | 0.56 (0.43-0.73) | 0.42 (0.34-0.51) | 0.47 (0.33-0.67) | Not reported | ||||
| Median PFS (months) | NR | 31.9 | 36.4 | 19.3 | NR | NR | NR | NR |
| HR OS (95% CI) | Not reported | 0.61 (0.46-0.80) | 0.43 (0.23-0.80) | Not reported | ||||
| Median OS (months) | NR | NR | NR | NR | NR | NR | NR | NR |
| Grade ≥ 3 neutropenia | 50.0 | 35.3 | 40† | 39† | 28 | 15 | 41 | 22 |
| Grade ≥ 3 infections | 32.1 | 23.3 | 22† | 15† | 22 | 20 | 23 | 22 |
| Grade ≥ 3 Pneumonia | 13.7 | 7.9 | 11† | 4.2† | Not reported | Not reported | 13‡ | 15‡ |
| Infusion-related reactions (all grade) | 40.9 | NA | 27.7 | NA | 35 | NA | 42 | NA |
| . | MAIA . | ALCYONE . | CASSIOPEIA . | GRIFFIN . | ||||
|---|---|---|---|---|---|---|---|---|
| Regimen | Dara-Rd | Rd | Dara-VMP | VMP | Dara-VTd | VTd | Dara-VRd | VRd |
| HDM | HDM | HDM | HDM | |||||
| Dara-VTd | VTD | Dara-VRd | VRd | |||||
| R2: observation or dara maintenance (2 y) | R2: observation or dara maintenance (2 y) | Dara + len maintenance (Dara 2 y) | len maintenance | |||||
| No. of patients | 368 | 369 | 350 | 356 | 543 | 542 | 104 | 103 |
| Patient population | NDMM, ineligible for transplant | NDMM, ineligible for transplant | NDMM, eligible for transplant | NDMM, eligible for transplant | ||||
| ECOG PS 0-2 | ECOG PS 0-2 | ECOG PS 0-2 | ECOG PS 0-2 | |||||
| Creatinine clearance: ≥30 mL/min | Creatinine clearance: ≥40 mL/min | Creatinine clearance: ≥40 mL/min | Creatinine clearance: ≥30 mL/min | |||||
| Median follow-up, mo | 28 | 40.1 | 18.8 | 22.1 | ||||
| ≥PR | 92.9 | 81.3 | 90.9 | 73.9 | 92.6* | 89.9* | 99.0* | 91.8* |
| (s)CR | 47.6 | 24.9 | 46 | 25 | 39* | 26* | 51.5* | 42.3* |
| MRD negativity (10−5) | 24.2 | 7.3 | 28 | 7 | 64 | 44* | 51.0 | 20.4 |
| HR PFS (95% CI) | 0.56 (0.43-0.73) | 0.42 (0.34-0.51) | 0.47 (0.33-0.67) | Not reported | ||||
| Median PFS (months) | NR | 31.9 | 36.4 | 19.3 | NR | NR | NR | NR |
| HR OS (95% CI) | Not reported | 0.61 (0.46-0.80) | 0.43 (0.23-0.80) | Not reported | ||||
| Median OS (months) | NR | NR | NR | NR | NR | NR | NR | NR |
| Grade ≥ 3 neutropenia | 50.0 | 35.3 | 40† | 39† | 28 | 15 | 41 | 22 |
| Grade ≥ 3 infections | 32.1 | 23.3 | 22† | 15† | 22 | 20 | 23 | 22 |
| Grade ≥ 3 Pneumonia | 13.7 | 7.9 | 11† | 4.2† | Not reported | Not reported | 13‡ | 15‡ |
| Infusion-related reactions (all grade) | 40.9 | NA | 27.7 | NA | 35 | NA | 42 | NA |
CR, complete response; dara, daratumumab; Dara-Rd, daratumumab-lenalidomide-dexamethasone; Dara-VMP, daratumumab-bortezomib-melphalan-prednisone; Dara-VRd, daratumumab-bortezomib-lenalidomide-dexamethasone; Dara-VTd, daratumumab-bortezomib-thalidomide-dexamethasone; HR, hazard ratio; len, lenalidomide; NA, not applicable; NR, not reached; PR, partial response; R2, second randomization; Rd, lenalidomide-dexamethasone; VMP, bortezomib-melphalan-prednisone; VRd, bortezomib-lenalidomide-dexamethasone; VTd, bortezomib-thalidomide-dexamethasone;
Response after consolidation.
During cycles 1-9.
Any grade pneumonia..