CD38 antibodies plus lenalidomide-dexamethasone in relapsed/refractory MM
| . | NCT02076009 (POLLUX)59,62 . | NCT0174996964 . | NCT0142118636,65 . | |
|---|---|---|---|---|
| Phase | Phase 3 | Phase 1b | Phase 1/2a | |
| Regimen | Rd | DRd | Isatuximab-Rd | MOR202-Rd |
| Treatments | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Daratumumab (16 mg/kg): weekly for 8 wk, then Q2W for 16 wk, thereafter Q4W | Isatuximab: 3, 5, or 10 mg/kg Q2W or 10, 20 mg/kg QW for 4 wk, and then Q2W | MOR202 8-16 mg/kg, weekly |
| Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle | |
| Treatment until progression | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Dexamethasone: 40 mg weekly | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | |
| Treatment until progression | Treatment until progression | Treatment until progression or a maximum of 2 y | ||
| No. of patients | 283 | 286 | 57 (52 evaluable for response) | 15 (13 evaluable for response) |
| Median age, y | 65 | 65 | 61 | 64 |
| Median no. of prior therapies | 1 | 1 | 5 | 2 |
| Len-refractory, % | Len-refractory patients were excluded | Len-refractory patients were excluded | 82 | 13 |
| Bort-refractory, % | 16.3 | 19.9 | 65 | 27 |
| IRR, % | Not applicable | 47.7 | 56 | 6.7 |
| ≥PR, % | 76.4 | 92.9 | 55.7 (Len-refractory: 52.4%) | 84.6 |
| ≥VGPR, % | 44.2 | 75.8 | 36.5 (Len-refractory: 35.7%) | 23.1 |
| ≥CR, % | 19.2 | 43.1 | 3.8 (Len-refractory: 0.0%) | 0.0 |
| MRD− disease (10−5), % | 5.7 | 24.8 | NA | NA |
| PFS | 12-mo: 60.1% | 12 mo: 83.2% | Median: 8.5 mo 12 mo: 38.9% | Median: not reached |
| OS | 12 mo: 86.8% | 12 mo: 91.2% | Not reported | Median: not reached |
| . | NCT02076009 (POLLUX)59,62 . | NCT0174996964 . | NCT0142118636,65 . | |
|---|---|---|---|---|
| Phase | Phase 3 | Phase 1b | Phase 1/2a | |
| Regimen | Rd | DRd | Isatuximab-Rd | MOR202-Rd |
| Treatments | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Daratumumab (16 mg/kg): weekly for 8 wk, then Q2W for 16 wk, thereafter Q4W | Isatuximab: 3, 5, or 10 mg/kg Q2W or 10, 20 mg/kg QW for 4 wk, and then Q2W | MOR202 8-16 mg/kg, weekly |
| Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle (10 mg if CrCl 30-60 mL/min) | Lenalidomide: 25 mg on days 1-21 per 28-d cycle | |
| Treatment until progression | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Dexamethasone: 40 mg weekly | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | |
| Treatment until progression | Treatment until progression | Treatment until progression or a maximum of 2 y | ||
| No. of patients | 283 | 286 | 57 (52 evaluable for response) | 15 (13 evaluable for response) |
| Median age, y | 65 | 65 | 61 | 64 |
| Median no. of prior therapies | 1 | 1 | 5 | 2 |
| Len-refractory, % | Len-refractory patients were excluded | Len-refractory patients were excluded | 82 | 13 |
| Bort-refractory, % | 16.3 | 19.9 | 65 | 27 |
| IRR, % | Not applicable | 47.7 | 56 | 6.7 |
| ≥PR, % | 76.4 | 92.9 | 55.7 (Len-refractory: 52.4%) | 84.6 |
| ≥VGPR, % | 44.2 | 75.8 | 36.5 (Len-refractory: 35.7%) | 23.1 |
| ≥CR, % | 19.2 | 43.1 | 3.8 (Len-refractory: 0.0%) | 0.0 |
| MRD− disease (10−5), % | 5.7 | 24.8 | NA | NA |
| PFS | 12-mo: 60.1% | 12 mo: 83.2% | Median: 8.5 mo 12 mo: 38.9% | Median: not reached |
| OS | 12 mo: 86.8% | 12 mo: 91.2% | Not reported | Median: not reached |
Bort, bortezomib; CR, complete response; CrCl, creatinine clearance; DRd, daratumumab plus lenalidomide-dexamethasone; IRR, infusion-related reaction; Len, lenalidomide; MRD, minimal residual disease; NA, not assessed; OS, overall survival; PFS, progression-free survival; PR, partial response; Q2W, once every 2 weeks; Q4W, once every 4 weeks; QW, once weekly; Rd, lenalidomide-dexamethasone; VGPR, very-good partial response.