Table 1.
Daratumumab.
| Treatment | Clinical trials | Patient population | ORR% | PFS | OS at 12 m | Date of approval |
|---|---|---|---|---|---|---|
| D monotherapy | GEN501 | RRMM | 36* | 5.6 m | 77%* | Nov 16, 2015 |
| SIRIUS | RRMM | 29.2 | 3.7 m | 64.8% | ||
| POLLUX | RRMM | 92.9 vs 76.4 |
12 m: 83.2 vs 60.1% |
92.1 vs 86.8% | Nov 21, 2016 | |
| D-Rd vs Rd | ||||||
| MAIA | NDMM transplant-ineligible | 92.9 vs 81.3 |
30 m: 70.6 vs 55.6% |
June 27, 2019 | ||
| D-Vd vs Vd | CASTOR | RRMM | 82.9 vs 63.2 | 12 m: 60.7 vs 26.9 % |
Nov 21, 2016 | |
| D plus PomDex | EQUULEUS | RRMM | 60 | 13.1 m: 8.8 m (median) | 66% (median) |
June 16, 2017 |
| D-VMP vs VMP | ALCYONE | NDMM transplant-ineligible | 90.9 vs 73.9 |
18 m: 71,6 vs 50.2% |
May 7, 2018 | |
| D-VTd vs VTd | CASSIOPEIA | NDMM transplant-eligible | 92.6 vs 89.9 |
18 m: 93 vs 85% |
Sept 26, 2019 | |
| D-RVd vs RVd | GRIFFIN | NDMM transplant-eligible | 99 vs 91.8 | 24 m: 95.8 vs 89.9 % |
*in the cohort of patients receiving 16 mg/kg dose.
NDMM, newly diagnosed MM patients; RRMM, relapsed refractory MM patients; D, daratumumab; R, lenalidomide; Pom, pomalidomide; V, bortezomib; M, melphalan; T, thalidomide; P, prednisone; d, dexamethasone; ORR, overall response rate; PFS, progression free survival; OS, overall survival; m, months.