Phase 3 studies evaluating Rd-based triplets in early RRMM
| . | POLLUX62-64 . | ELOQUENT-265,66 . | ASPIRE67,68 . | TOURMALINE-MM115 . |
|---|---|---|---|---|
| No. of patients | 569 | 646 | 792 | 722 |
| Regimen | dara-Rd vs Rd | elo-Rd vs Rd | KRd vs Rd | IRd vs Rd |
| Patient population | • At least 1 prior line of therapy; len-refractory patients were excluded• Creatinine clearance ≥30 mL/min | • 1-3 prior lines of therapy; len-refractory patients were excluded• Creatinine clearance ≥30 mL/min | • 1-3 prior lines of therapy; len-refractory and PI-refractory patients were excluded• Creatinine clearance ≥50 mL/min | • 1-3 prior lines of therapy; len-refractory and PI-refractory patients were excluded• Creatinine clearance ≥30 mL/min |
| Prior len % / len-refractory % | 17.6 / NA | 6 / NA | 19.8 / 7.2 | 12 / 0.1 |
| Prior bort % / bort-refractory % | 84.2 / 20.6 | 70 / NA | 65.8 / 14.9 | 69 / 2* |
| CD38 antibody exposed, % | 0? | 0 ? | 0? | 0? |
| Median follow-up, mo | 44.3 | 46 | For PFS: 32.3For OS: 67.1 | 14.8 |
| ≥PR, % | 92.9 vs 76.4 | 79 vs 66 | 87.1 vs 66.7 | 78.3 vs 71.5 |
| ≥CR, % | 56.6 vs 23.2 | 5 vs 9 | 31.8 vs 9.3 | 14.2 vs 6.6 |
| HR PFS (95% CI) | 0.44 (0.35-0.55); P < .0001 | 0.71 (0.59-0.86); P = .0004 | 0.69 (0.57-0.83); P = .0001 | 0.74 (0.59-0.94); P = .01 |
| HR OS (95% CI) | HR for OS not reported; 42-mo OS: 65% vs 57% | 0.78 (0.63-0.96); P = not reported | 0.79 (0.67-0.95); P = .0045 | No OS benefit shown |
| . | POLLUX62-64 . | ELOQUENT-265,66 . | ASPIRE67,68 . | TOURMALINE-MM115 . |
|---|---|---|---|---|
| No. of patients | 569 | 646 | 792 | 722 |
| Regimen | dara-Rd vs Rd | elo-Rd vs Rd | KRd vs Rd | IRd vs Rd |
| Patient population | • At least 1 prior line of therapy; len-refractory patients were excluded• Creatinine clearance ≥30 mL/min | • 1-3 prior lines of therapy; len-refractory patients were excluded• Creatinine clearance ≥30 mL/min | • 1-3 prior lines of therapy; len-refractory and PI-refractory patients were excluded• Creatinine clearance ≥50 mL/min | • 1-3 prior lines of therapy; len-refractory and PI-refractory patients were excluded• Creatinine clearance ≥30 mL/min |
| Prior len % / len-refractory % | 17.6 / NA | 6 / NA | 19.8 / 7.2 | 12 / 0.1 |
| Prior bort % / bort-refractory % | 84.2 / 20.6 | 70 / NA | 65.8 / 14.9 | 69 / 2* |
| CD38 antibody exposed, % | 0? | 0 ? | 0? | 0? |
| Median follow-up, mo | 44.3 | 46 | For PFS: 32.3For OS: 67.1 | 14.8 |
| ≥PR, % | 92.9 vs 76.4 | 79 vs 66 | 87.1 vs 66.7 | 78.3 vs 71.5 |
| ≥CR, % | 56.6 vs 23.2 | 5 vs 9 | 31.8 vs 9.3 | 14.2 vs 6.6 |
| HR PFS (95% CI) | 0.44 (0.35-0.55); P < .0001 | 0.71 (0.59-0.86); P = .0004 | 0.69 (0.57-0.83); P = .0001 | 0.74 (0.59-0.94); P = .01 |
| HR OS (95% CI) | HR for OS not reported; 42-mo OS: 65% vs 57% | 0.78 (0.63-0.96); P = not reported | 0.79 (0.67-0.95); P = .0045 | No OS benefit shown |
bort, bortezomib; CI, confidence interval; CR, complete response; dara-Rd, daratumumab-lenalidomide-dexamethasone; elo-Rd, elotuzumab-lenalidomide-dexamethasone; HR, hazard ratio; IRd, ixazomib-lenalidomide-dexamethasone; KRd, carfilzomib-lenalidomide-dexamethasone; len, lenalidomide; NA, not available; PI, proteasome inhibitor; PR, partial response; Rd, lenalidomide-dexamethasone.
Refractory to any PI.