Isatuximab and LEN plasma PK parameters
| Mean ± SD (geometric mean) [CV%] . | Isatuximab, single IV infusion . | LEN 25 mg, single and repeated oral administration . | |||||
|---|---|---|---|---|---|---|---|
| 3 mg/kg Q2W (n = 2) . | 5 mg/kg Q2W (n = 3) . | 10 mg/kg Q2W (n = 17) . | 10 mg/kg QW (n = 7) . | 20 mg/kg QW (n = 5) . | Day 1 (n = 29) . | Day 15 (n = 14) . | |
| Cmax, μg/mL | 68.3 ± NC (67.8) [NC] | 98.1 ± 49.7 (90.7) [51] | 212 ± 96.5 (193) [46] | 122 ± 29 (119) [24] | 257 ± 133 (232) [52] | 315 ± 129 (285) [41] | 347 ± 147 (316) [42] |
| tmax,* h | 6.10 (3.25-9.87) | 3.90 (2.75-5.65) | 5.75 (2.25-11.17) | 6.0 (2.70-21.92) | 8.72 (5.10-24.0) | 2.00 (0.92-4.25) | 2.24 (0.58-8.25) |
| AUC0-1wk, μg·h/mL | 4240 ± NC (3940) [NC] | 6560 ± 3110 (6120) [47] | 15 800 ± 6 690 (14 400) [42] | 10 100 ± 2 690 (9800) [38] | 20 300 ± 7 740 (19 000) [38] | NC | NC |
| AUC0-2wk, μg·h/mL | 5080 ± NC (4560) [NC] | 8360 ± 4560 (7620) [55] | 21 700 ± 10 100 (19 100) [46] | NC | NC | NC | NC |
| AUC0-24h, ng·h/mL | NC | NC | NC | NC | NC | 2720 ± 1460 (2370) [54]† | 2950 ± 1290 (2720) [44]‡ |
| Mean ± SD (geometric mean) [CV%] . | Isatuximab, single IV infusion . | LEN 25 mg, single and repeated oral administration . | |||||
|---|---|---|---|---|---|---|---|
| 3 mg/kg Q2W (n = 2) . | 5 mg/kg Q2W (n = 3) . | 10 mg/kg Q2W (n = 17) . | 10 mg/kg QW (n = 7) . | 20 mg/kg QW (n = 5) . | Day 1 (n = 29) . | Day 15 (n = 14) . | |
| Cmax, μg/mL | 68.3 ± NC (67.8) [NC] | 98.1 ± 49.7 (90.7) [51] | 212 ± 96.5 (193) [46] | 122 ± 29 (119) [24] | 257 ± 133 (232) [52] | 315 ± 129 (285) [41] | 347 ± 147 (316) [42] |
| tmax,* h | 6.10 (3.25-9.87) | 3.90 (2.75-5.65) | 5.75 (2.25-11.17) | 6.0 (2.70-21.92) | 8.72 (5.10-24.0) | 2.00 (0.92-4.25) | 2.24 (0.58-8.25) |
| AUC0-1wk, μg·h/mL | 4240 ± NC (3940) [NC] | 6560 ± 3110 (6120) [47] | 15 800 ± 6 690 (14 400) [42] | 10 100 ± 2 690 (9800) [38] | 20 300 ± 7 740 (19 000) [38] | NC | NC |
| AUC0-2wk, μg·h/mL | 5080 ± NC (4560) [NC] | 8360 ± 4560 (7620) [55] | 21 700 ± 10 100 (19 100) [46] | NC | NC | NC | NC |
| AUC0-24h, ng·h/mL | NC | NC | NC | NC | NC | 2720 ± 1460 (2370) [54]† | 2950 ± 1290 (2720) [44]‡ |