Table 2.
Summary of Daratumumab Serum Concentrations Over Time in MMY1001 D-Kd and D-KRd Dose Cohorts
| Sampling time point | D-Kd | D-KRd | Combined | ||
|---|---|---|---|---|---|
| Single dose | Split dose | Split dose | Split dose | ||
| PK-evaluable patients, n | 10 | 75 | 22 | 97 | |
| C1D1 postinfusiona | |||||
| n | 8 | 71 | 15 | 86 | |
| Median (range), μg/ml | 319.2 (237.5–394.7) | 151.5 (82.5–345.0) | 177.8 (121.9–215.7) | 156.7 (82.5–345.0) | |
| CV (%) | 15.3 | 31.5 | 16.8 | 29.3 | |
| C1D2 preinfusionb | |||||
| n | NA | 65 | 16 | 81 | |
| Median (range), μg/ml | – | 110.5 (0.0–284.9) | 118.0 (61.2–169.2) | 111.6 (0.0–284.9) | |
| CV (%) | – | 37.9 | 24.5 | 35.4 | |
| C1D2 postinfusiona | |||||
| N | NA | 69 | 18 | 87 | |
| Median (range), μg/ml | – | 254.9 (125.8–435.5) | 277.2 (164.0–341.8) | 256.8 (125.8–435.5) | |
| CV (%) | – | 28.2 | 20.8 | 26.7 | |
| C2D1 preinfusionb | |||||
| N | 10 | 63 | 21 | 84 | |
| Median (range), μg/ml | 335.8 (186.6–556.4) | 380.7 (0.0–721.6) | 329.8 (112.1–473.4) | 354.7 (0.0–721.6) | |
| CV (%) | 34.5 | 49.4 | 32.9 | 47.0 | |
| C2D1 postinfusiona | |||||
| N | 9 | 64 | 15 | 79 | |
| Median (range), μg/ml | 726.6 (523.1–911.6) | 688.6 (0.0–1202.4) | 692.4 (458.8–961.0) | 688.9 (0.0–1202.4) | |
| CV (%) | 22.1 | 36.4 | 23.1 | 34.3 | |
| C3D1 preinfusionb | |||||
| N | 9 | 52 | 19 | 71 | |
| Median (range), μg/ml | 463.2 (355.9–792.9) | 663.9 (57.7–1110.7) | 575.1 (237.9–825.5) | 639.2 (57.7–1110.7) | |
| CV (%) | 26.5 | 41.4 | 30.7 | 39.1 | |
| C3D1 postinfusiona | |||||
| N | 9 | 52 | 14 | 66 | |
| Median (range), μg/ml | 844.1 (725.4–1176.0) | 916.0 (36.9–1711.3) | 939.3 (638.4–1301.0) | 926.0 (36.9–1711.3) | |
| CV (%) | 18.9 | 36.8 | 17.9 | 33.5 | |
| C4D1 preinfusionb | |||||
| N | 7 | 24 | 21 | 45 | |
| Median (range), μg/ml | 509.1 (291.2–743.5) | 613.0 (92.3–1019.3) | 457.3 (146.1–768.1) | 523.0 (92.3–1019.3) | |
| CV (%) | 30.9 | 41.8 | 33.2 | 39.2 | |
| C4D1 postinfusiona | |||||
| N | 8 | 24 | 11 | 35 | |
| Median (range), μg/ml | 918.6 (646.5–1142.6) | 962.0 (347.0–1630.2) | 939.4 (776.6–1205.0) | 939.4 (347.0–1630.2) | |
| CV (%) | 19.2 | 31.3 | 15.3 | 27.0 | |
D-Kd daratumumab/carfilzomib/dexamethasone, D-KRd daratumumab/carfilzomib/lenalidomide/dexamethasone, PK pharmacokinetics, C cycle, D day, SD standard deviation, CV coefficient of variation, NA not applicable
aPostinfusion PK sampling time window was up to 5 min after the end of infusion
bPreinfusion PK sampling time window was up to 2 h prior to the start of the infusion or administration of the backbone medications