Randomized phase 2 and 3 studies evaluating pomalidomide-based triplets in patients with RRMM
. | isa-Pd vs Pd28 . | PCd vs Pd29 . | elo-Pd vs Pd33 . |
---|---|---|---|
Phase | Randomized phase 3 | Randomized phase 2 | Randomized phase 2 |
No. of patients | 307 | 70 | 117 |
Median of prior lines | 3 | 4 | 3 |
Len-refractory, % | 93 | 100 | 87 |
Bort-refractory, % | 76* | 74 | 80* |
Median follow-up, mo | 11.6 | Not reported | Minimum follow-up of 9.1 mo |
≥PR, % | 60 vs 35 | 65 vs 39 | 53 vs 26 |
≥VGPR, % | 32 vs 9 | 12 vs 14 | 20 vs 9 |
Median PFS, mo | 11.5 vs 6.5 | 9.5 vs 4.4 | 10.3 vs 4.7 mo |
Median OS, mo | 1-y OS: 72% vs 63% | Not reached vs 16.8 | Not reached in both arms |
Approval | FDA/EMA | — | FDA/EMA |
. | isa-Pd vs Pd28 . | PCd vs Pd29 . | elo-Pd vs Pd33 . |
---|---|---|---|
Phase | Randomized phase 3 | Randomized phase 2 | Randomized phase 2 |
No. of patients | 307 | 70 | 117 |
Median of prior lines | 3 | 4 | 3 |
Len-refractory, % | 93 | 100 | 87 |
Bort-refractory, % | 76* | 74 | 80* |
Median follow-up, mo | 11.6 | Not reported | Minimum follow-up of 9.1 mo |
≥PR, % | 60 vs 35 | 65 vs 39 | 53 vs 26 |
≥VGPR, % | 32 vs 9 | 12 vs 14 | 20 vs 9 |
Median PFS, mo | 11.5 vs 6.5 | 9.5 vs 4.4 | 10.3 vs 4.7 mo |
Median OS, mo | 1-y OS: 72% vs 63% | Not reached vs 16.8 | Not reached in both arms |
Approval | FDA/EMA | — | FDA/EMA |
—, no approval by FDA/EMA; Bort, bortezomib; elo-Pd, elotuzumab-pomalidomide-dexamethasone; isa-Pd, isatuximab-pomalidomide-dexamethasone; Len, lenalidomide; PCd, pomalidomide-cyclophosphamide-dexamethasone; Pd, pomalidomide-dexamethasone.
Refractory to at least 1 PI.