Table 1.
Results of isatuximab and daratumumab randomized phase 3 trials in combination with pomalidomide and dexamethasone in patients with RRMM
| ICARIA-MM 48 Isa-Pd N = 307 |
APOLLO 61,68 Dara-Pd N = 304 |
||||
|---|---|---|---|---|---|
| Administration | IV | IV and SCa | |||
| Median lines of prior therapy, n | 3 | 2 | |||
| Refractory to Len/PI/Len + PI, % | 93/76/71 | 80/48/42 | |||
| High-risk cytogeneticsb, % | 20 | 35c | |||
| Regimen |
Isa-Pd (n = 154) |
Pd (n = 153) |
Dara-Pd (n = 151) |
Pd (n = 153) |
|
| Median follow-up, mo | 11.6 | 16.9 | |||
| Efficacy | Median PFS, mo | 11.5 | 6.5 | 12.4 | 6.9 |
| PFS HR (95% CI) P-value |
0.596 (0.44–0.81) P = .001 |
0.63 (0.47–0.85) P = .0018 |
|||
| ORR, % | 60.4 | 35.3 | 69 | 46 | |
| ≥ VGPR, % | 31.8 | 8.5 | 51 | 19.6 | |
| ≥ CRd, % | 4.5 | 2 | 24.5 | 3.9 | |
| MRD-, % | 5 | 0 | 9 | 2 | |
| Safety |
Neutropenia (≥ grade 3), % |
85 | 70 | 68 | 51 |
| Discontinued due to AE, % | 7.2 | 12.8 | 2 | 3 | |
AE, adverse event; CI, confidence interval; CR, complete response; d, dexamethasone; Dara, daratumumab; HR, hazard ratio; Isa, isatuximab; IV, intravenous; mo, months; MRD, minimal residual disease; ORR, overall response rate; P, pomalidomide; PFS, progression-free survival; SC, subcutaneous; VGPR, very good partial response
a Prior to protocol amendment, patients received daratumumab IV; after protocol amendment, all patients received daratumumab SC co-formulated with recombinant human hyaluronidase
b Based on fluorescence in situ hybridization; defined as presence of del(17p), t(14;16), or t(4;14). c Reported in assessable patients. d Rates reported reflect patients achieving either complete response or stringent complete response