Table 2.
Selected subgroup analyses from isatuximab and daratumumab randomized phase 3 trials in combination with pomalidomide and dexamethasone
| Subgroup | ICARIA-MM 48,69,70 Isa-Pd vs. Pd |
APOLLO 61,68 Dara-Pd vs. Pd |
||
|---|---|---|---|---|
| PFS HR (95% CI) | Pinteraction | PFS HR (95% CI) | Pinteraction | |
| Age | 0.5952 | NR | ||
| < 65 yr | 0.66 (0.40–1.07) | 0.69 (0.44–1.09) | ||
| ≥ 65 yr | 65–74 yr: 0.64 (0.39–1.06) ≥ 75 yr: 0.48 (0.24–0.95) | 0.55 (0.38–0.81) | ||
| Previous lines of therapy | 0.9583 | NR | ||
| 1 | –a | 0.70 (0.30–1.67) | ||
| 2–3 | 0.59 (0.40–0.88) | 0.66 (0.48–0.92) | ||
| > 3 | 0.59 (0.36–0.98) | 0.40 (0.18–0.90) | ||
| Baseline renal functionb |
eGFR (mL/min/1.73 m2) ≥ 60: 0.58 (0.38–0.88) < 60: 0.50 (0.30–0.85) |
0.7575 |
CrCl (mL/min) > 60: 0.64 (0.45–0.90) ≤ 60: 0.59 (0.35–0.99) |
NR |
| Cytogenetic riskc | 0.9990 | NR | ||
| High risk | 0.66 (0.33–1.28) | 0.85 (0.49–1.44) | ||
| Standard risk | 0.62 (0.42–0.93) | 0.51 (0.32–0.81) | ||
| Soft-tissue plasmacytomas | 0.22 (0.07–0.69) | NR | NA | |
| Gain 1q21 | 0.50 (0.28–0.88) | NR | NA | |
CI, confidence interval; CrCl, creatinine clearance; d, dexamethasone; Dara, daratumumab; eGFR, estimated glomerular filtration rate; HR, hazard ratio; Isa, isatuximab; MDRD, Modification of Diet in Renal Disease; NA, not analyzed; NR, not reported; P, pomalidomide; PFS, progression-free survival; yr, year
The differences in patient characteristics between the studies and limited sample size in the subgroup
Analyses prevent comparisons across trials
aAll patients in ICARIA-MM had received at least 2 lines of prior therapy
bMeasured as estimated glomerular filtration rate (by MDRD equation) in ICARIA-MM and as creatinine clearance (method not specified) in APOLLO
cBased on fluorescence in situ hybridization; high risk defined as del(17p), t(4;14), or t(4;16)