Pharmacokinetic parameters for spartalizumab, by treatment group
| 1 mg/kg Q2W n=16 | 3 mg/kg Q2W n=15 | 10 mg/kg Q2W n=10 | 3 mg/kg Q4W n=6 | 5 mg/kg Q4W n=10 | |
| Cycle 1 | |||||
| n | 15 | 12 | 8 | 6 | 9 |
| AUCtau (day*µg/mL) | 131.5 (36.39) | 333.0 (100.17) | 1242.0 (238.59) | 556.4 (210.88) | 940.1 (484.87) |
| n | 14 | 13 | 9 | 6 | 7 |
| Cmax (µg/mL) | 18.7 (4.88) | 56.6 (14.50) | 185.9 (34.85) | 55.7 (16.43) | 114.7 (45.51) |
| n | 14 | 13 | 9 | 6 | 7 |
| Tmax (hours) | 1.6 (1.38–2.12) | 1.58 (1.25–1.7) | 1.57 (1.5–1.68) | 1.55 (1.5–1.83) | 1.58 (1.5–1.67) |
| n | 15 | 12 | 8 | 6 | 8 |
| T1/2 (days) | 12.7 (4.08) | 11.1 (4.32) | 13.2 (5.64) | 19.4 (11.37) | 24.3 (22.22) |
| Cycle 3 | |||||
| n | 8 | 3 | 4 | 2 | 2 |
| AUCtau (day*µg/mL) | 297.3 (127.90) | 1411.5 (673.38) | 3226.6 (977.15) | 1035.4 (173.20) | 2816.3 (727.94) |
| n | 10 | 6 | 3 | 2 | 2 |
| Cmax (µg/mL) | 31.8 (12.40) | 120.0 (33.60) | 320.7 (92.74) | 66.1 (0.21) | 187.5 (78.49) |
| n | 10 | 6 | 3 | 2 | 2 |
| Tmax (hours) | 1.55 (1.45–1.75) | 1.57 (1.5–1.58) | 1.58 (1.52–1.62) | 1.53 (1.5–1.57) | 1.3 (0.78–1.82) |
| n | 7 | 3 | 4 | 2 | 2 |
| T1/2 (days) | 15.7 (6.71) | 18.7 (4.46) | 21.4 (7.68) | 25.2 (4.45) | 41.3 (4.62) |
Mean values (SD) provided, except for Tmax, which is median (range).
AUCtau, area under the curve, 0–672 hours for Q4W or 0–336 hours for Q2W; Cmax, maximum serum concentration; Q2W, once every 2 weeks; Q4W, once every 4 weeks; T1/2, half life; Tmax, time at Cmax.