Table 1.
Results of the main clinical trials with anti-CD38 monoclonal antibodies daratumumab and isatuximab.
| Study | Phase | Number of Patients | Median Previous Line | Regimen | ORR | Median PFS (Months) |
Median OS (Months) |
|---|---|---|---|---|---|---|---|
| RELAPSED PATIENTS | |||||||
| GEN501 + SIRIUS POOLED [28] | II | 148 | 5 | Daratumumab single agent | 31.1% | 4 | 20.1 |
| POLLUX [29] | III | 569 | 1 | Dara-Rd vs. Rd | 92.9% vs. 76.4% | NR vs. 17.5 | 1-year OS 92.1% vs. 86.8% |
| CASTOR [30,31] | III | 498 | 2 | Dara-Vd vs. Vd | 83.8% vs. 63.2% | 16.7 vs. 7.1 | NA |
| NCT01998971 [32] | II | 103 | 4 | Dara-Poma-dex | 60% | 8.8 | 17.5 |
| NCT01998971 [33] | Ib | 85 | 2 | Dara-Kd | 84% | 1-year PFS 74% | 1-year OS 82% |
| NCT01749969 [34] | Ib | 57 | 5 | Isa-Rd | 56% | 8.5 | NR |
| NCT02283775 [35] | Ib | 45 | 3 | Isa-Pd | 62% | 17.6 | NR |
| NCT02332850 [36] | Ib | 33 | 3 | Isa-Kd | 66% | NR | NR |
| ICARIA [37] | III | 307 | 3 | Isa-Pd vs. Pd | 60% vs. 35% | 11.5 vs. 6.5 |
NA |
| NEWLY DIAGNOSED PATIENTS | |||||||
| ALCYONE [11] | III | 706 TNE | − | Dara-VMP vs. VMP | 90.9% vs. 73.9% | NR vs. 18.1 | NA |
| MAIA [38] | III | 737 TNE | − | Dara-Rd vs. Rd | 92.9% vs. 81.3% | NR vs. 31.9 | NA |
| CASSIOPEIA [39] | III | 1085 TE | − | Dara-VTd vs. VTd | ≥CR 39% vs. 26% | NA | NA |
| GRIFFIN [40] | II | 207 TE | − | Dara-VRd vs VRd | 51.5% vs. 42.3% | NA | NA |
Abbreviations: ORR, overall response rate; PFS, progression-free survival; OS, overall survival; Dara, daratumumab; Isa, isatuximab; V, bortezomib; C, cyclophosphamide; d, dex, dexamethasone; T, thalidomide; R, lenalidomide; K, carfilzomib; Poma, pomalidomide; M, melphalan; P, prednisone; NR, not reached; NA, not yet available; TNE, transplant ineligible; TE, transplant eligible; CR, complete response.