Table 1.
Overview of important clinical studies of CD38-directed monoclonal antibodies.
| Study Reference | Study Group/Intervention | Phase | Median nr of Prior Lines | ORR (%) | PFS (Median; Months) | OS (Median; Months) |
|---|---|---|---|---|---|---|
| RRMM | ||||||
| Monotherapy | ||||||
| [19,20,21] * | Daratumumab | 2 | 4 | 31.1 | 4 | 20.1 |
| [22,23] | Isatuximab | 2 | 5 | 24.3 | 3.6 | 18.6 |
| [24] | MOR202 | 2 | 4 | 29 | NR | NR |
| [25] | TAK-079 | 1/2a | 3 | 56 (300 mg) 33 (600 mg) | 3.7 (300 mg) NR (600 mg) |
NR |
| Combination therapy | ||||||
| IMiD based | ||||||
| [26,27,28] | DRd vs. Rd | 3 | 1 | 93 vs. 76 | 44.5 vs. 17.5 | NR |
| [29] | Isatuximab-Rd | 1b | 5 | 56 | 8.5 | NR |
| [30] | DPd | 1b | 4 | 60 | 8.8 | 17.5 |
| [31] | Isatuximab-Pd vs. Pd | 3 | 3 | 61 vs. 36 | 11.5 vs. 6.5 | At 12 months: 72% vs. 63% |
| PI based | ||||||
| [32,33] | DVd vs. Vd | 3 | 2 | 83 vs. 63 | 16.7 vs. 7.1 | NR |
| [34] | DKd | 1b | 2 | 84 | NR | NR |
| [35] | DKd vs. Kd | 3 | 84.3 vs. 74.7 | NR vs. 15.8 | NR (HR 0.75) | |
| NDMM | ||||||
| Combination therapy | ||||||
| [36,37,38] | Dara-VMP vs. VMP (NTE) | 3 | n.a. | 91 vs. 74 | 36.4 vs. 19.3 | NR (HR 0.6) |
| [39,40] | DRd vs. Rd (NTE) | 3 | n.a. | 93 vs. 82 | NR vs. 33.8 | NR |
| [41] | Dara-VTd vs. VTd (TE) | 3 | n.a. | 92.6 vs. 89.9 | NR (HR 0.47) | NR |
| [42] | D-VRd vs. VRd (TE) | 2 | n.a. | ≥CR: 79.8% vs. 60.8% | NR | NR |
* Data from the pooled analysis (21) of both trials (19, 20) are shown. Abbreviations: ORR: overall response rate; PFS: progression-free survival; OS: overall survival; RRMM: relapsed/refractory multiple myeloma; IMiD: immunomodulatory drugs; DRd: daratumumab-lenalidomide-dexamethasone; DPd: daratumumab-pomalidomide-dexamethasone; PI: proteasome inhibitor; DVd: daratumumab-bortezomib-dexamethasone; DKd: daratumumab-carfilzomib-dexamethasone; NDMM: newly-diagnosed multiple myeloma; VMP: bortezomib-melphalan-prednisone; NTE: non-transplant eligible; VTd: bortezomib-thalidomide-dexamethasone; TE: transplant eligible; D-VRd: daratumumab-bortezomib-lenalidomide-dexamethasone.