Table 4.
Summary of belantamab mafodotin, total monoclonal antibody and cys-mcMMAF pharmacokinetic parameter values at cycle 1 in patients receiving frozen-liquida or lyophilised presentation of belantamab mafodotin (safety population).
| Parameter | 2.5 mg/kg frozen-liquid (n = 95) | 3.4 mg/kg frozen-liquid (n = 99) | 3.4 mg/kg lyophilised (n = 24) | |||
|---|---|---|---|---|---|---|
| n | Value | n | Value | n | Value | |
| Belantamab mafodotin | ||||||
| AUC(0–τ) (μg•h/mL) | 30 | 4666 (46) | 20 | 5678 (40) | 22 | 5946 (37) |
| Cmax (μg/mL) | 32 | 42.5 (26) | 21 | 52.0 (20) | 22 | 51.3 (18) |
| tmax (h) | 32 | 0.78 (0.42–2.50) | 21 | 0.70 (0.43–2.15) | 22 | 0.75 (0.48–2.88) |
| Ctrough (μg/mL) | 69 | 2.43 (52) | 71 | 2.54 (88) | 20 | 3.41 (76) |
| Total monoclonal antibody | ||||||
| AUC(0–τ) (μg•h/mL) | 29 | 7305 (42) | 18 | 9566 (42) | 19 | 9029 (40) |
| Cmax (μg/mL) | 30 | 48.9 (30) | 19 | 61.1 (27) | 20 | 60.1 (18) |
| tmax (h) | 30 | 1.75 (0.42–2.50) | 19 | 1.87 (0.50–24.50) | 20 | 0.65 (0.48–2.17) |
| Ctrough (μg/mL) | 66 | 5.27 (83) | 71 | 5.98 (87) | 18 | 8.13 (101) |
| Cys-mcMMAF | ||||||
| AUC(0–168) (ng•h/mL) | 14 | 84.3 (59) | 12 | 109.4 (55) | 7 | 81.6 (58) |
| Cmax (pg/mL) | 27 | 903 (64) | 20 | 1148 (65) | 19 | 1017 (61) |
| tmax (h) | 27 | 22.83 (1.92–65.63) | 20 | 23.84 (17.38–72.65) | 19 | 24.08 (0.97–69.47) |
| Ctrough (pg/mL) | 82 | NQ (NQ–58.0) | 83 | NQ (NQ–452.5) | 24 | NQ (NQ–NQ) |
AUC area under the curve, Cmax maximum observed plasma concentration, Ctrough plasma concentration prior to next dose, cys-mcMMAF cysteine-maleimidocaproyl monomethyl auristatin F, NQ not quantifiable, tmax time of Cmax.
Data presented as geometric mean (%CVb), except tmax and Ctrough for cys-mcMMAF, presented as median (minimum–maximum).
aStudy population details, efficacy and safety analyses were previously reported16.