Table 1.
A summary of selected phase II and III clinical trials.
Study | POLLUX [23, 58] | ASPIRE [33, 34] | ELOQUENT-2 [22, 62] | TOURMALINE MM-1 [19] | CASTOR [20, 59] | ENDEAVOR [18] | MM-003 [17] | GEN501 and SIRIUS [54] |
---|---|---|---|---|---|---|---|---|
Regimen | DRd (vs. Rd) | KRd (vs. Rd) | ERd (vs. Rd) | IRd (vs. Rd) | DVd (vs. Vd) | Kd (vs. Vd) | Pd (vs. D) | Daratumumab |
N | 569 | 792 | 646 | 722 | 498 | 929 | 302 | 148 |
Median prior lines (range) | 1 (1–11) | 2 (1–3) | 2 (1–4) | 1–3 | 2 (1–9) | 2 (1–2) | 5 (2–14) | 5 |
ORR (≥VGPR, %) | 92.9 (75.8) | 87 (69.9) | 79 (35) | 72 (48) | 83.8 (62.1) | 77 (54) | 31 (6) | 31.1 (13.5) |
PFS (HR, mo) | N/R at 25.4 mo (HR, 0.41) | 26.3 (HR, 0.69) | 19.4 (HR, 0.70) | 20.6 (HR, 0.74) | 16.7 at 19.4 mo (HR, 0.31) | 18.7 (HR, 0.53) | 4.0 (HR, 0.48) | 4.0 |
OS (HR, mo) | 92.1% at 12 mo | 48.3 (HR, 0.79) | 48 (HR, 0.78) | N/A | N/A | 47.6 (HR, 0.79) | 11.9 (HR, 0.53) | 20.1 |
Abbreviations: D, high-dose dexamethasone; DRd, daratumumab-Rd; DVd, daratumumab-Vd; ERd, elotuzumab-Rd; HR, hazard ratio; IRd, ixazomib-Rd; Kd, carfilzomib-dexamethasone; KRd, carfilzomib-Rd; N, number of patients; N/A, not available; N/R, not reached; ORR, overall response rate; OS, overall survival; Pd, pomalidomide-dexamethasone; PFS, progression-free survival; Rd, lenalidomide-low-dose dexamethasone; Vd, bortezomib-dexamethasone; VGPR, very good partial response.