Table 3 Predicted summary statistics (median [min–max]) of atezolizumab exposure metrics
Metric | Observation | Body weight dose (<  18 years) | Flat dose (≥ 18 years) | ||||
|---|---|---|---|---|---|---|---|
<  30 kg n = 23 | 30 to < 45 kg n = 21 | ≥ 45 kg n = 25 | <  57 kg n = 6 | 57 to < 65 kg n = 6 | ≥ 65 kg n = 6 | ||
Cmax, μg/mL | Cycle 1 | 270 [182–349] | 330 [232–375] | 349 [281–407] | 492 [303–541] | 486 [419–549] | 326 [243–390] |
Steady-state | 400 [277–517] | 463 [257–585] | 460 [319–618] | 664 [377–764] | 651 [505–868] | 404 [334–540] | |
Cmin, μg/mL | Cycle 1 | 55.6 [28.1–82.0] | 65.0 [20.7–91.9] | 65.5 [27.4–108] | 97.3 [47.4–122] | 98.8 [56.9–151] | 57.6 [28.4–87.5] |
Steady-state | 120 [77.0–181] | 125 [25.4–246] | 112 [37.9–211] | 171 [74.1–225] | 164 [86.2–319] | 88.1 [32.4–149] | |
AUC, μg*day/mL | Cycle 1 | 2085 [1089–3053] | 2757 [1471–3312] | 2988 [1975–3954] | 4268 [2396–4845] | 4330 [3175–5448] | 2733 [2306–3701] |
Steady-state | 4045 [2536–5695] | 4781 [1730–7295] | 4510 [2417–7126] | 6692 [3365–8125] | 6574 [4276–10,405] | 3861 [2593–5774] | |
CL, mL/day/kg | – | 3.72 [2.62–5.89] | 3.20 [2.06–8.67] | 3.15 [2.90–6.10] | 3.62 [2.61–5.20] | 2.90 [1.99–4.92] | 3.25 [1.70–5.16] |