Talquetamab 40mg/1ml solution for injection vials

The C_max and AUC_tau of talquetamab after subcutaneous administration increased proportionally over a dose range of 0.005 to 0.8 mg/kg weekly (0.01 to 2 times the recommended 0.4 mg/kg weekly treatment dose) and 0.8 to 1.2 mg/kg every two weeks (1 to 1.5 times the recommended 0.8 mg/kg every two weeks treatment dose). Ninety percent of steady-state exposure was achieved 16 weeks after the first treatment dose for both regimens. Following the weekly administration of 0.4 mg/kg, the mean C_max (coefficient of variation, CV%) was 2940 ng/mL (67%), respectively.

Following the biweekly administration of 0.8 mg/kg, the C_max (CV%) was 3410 ng/mL (63%), respectively.
[L47765]


The geometric mean (coefficient of variation CV %) bioavailability of talquetamab was 59% (22%) when administered subcutaneously. The median (range) T_max of talquetamab after the first and 17th treatment dose of 0.4 mg/kg weekly were 3.7 (0.9 to 7) days and 2.5 (0.9 to 5.9) days, respectively. The median (range) T_max of talquetamab after the first and 9th treatment dose of 0.8 mg/kg every two weeks were 3.4 (0.8 to 14) days and 3.6 (1 to 7.7) days, respectively.
[L47765]