TABLE 4.
Therapeutic index of hFc-hIL-10 in cynomolgus monkeys.
| Method | Pharmacodynamic-based efficacious dose | Pharmacokinetic-based efficacious dose | |
|---|---|---|---|
| Efficacious dose (mg/kg) | 0.025 mg/kg | 0.020 mg/kg | 0.050 mg/kg |
| Q2W, Q3W, or Q4W | Q2W, Q3W, or Q4W for combination therapy with anti-PD-1 monoclonal antibody | Q2W, Q3W, or Q4W for monotherapy | |
| Dose (mg/kg) producing Grade 2 or less thrombocytopenia | 0.060 mg/kg Q2W, Q3W, or Q4W | ||
| Dose (mg/kg) producing Grade 2 or less anemia | 0.14 mg/kg Q2W | ||
| 0.24 mg/kg Q3W | |||
| 0.36 mg/kg Q4W | |||
| Therapeutic index versus thrombocytopeniaa | 2.4x | 3x | 1.2x |
| Therapeutic index versus anemia a | 5.6x (Q2W) | 7x (Q2W) | 2.8x (Q2W) |
| 9.6x (Q3W) | 12x (Q3W) | 4.8x (Q3W) | |
| 14x (Q4W) | 18x (Q4W) | 7.2x (Q4W) | |
a
The therapeutic index was calculated based on the ratio of the dose producing Grade 2 or less adverse events versus the efficacious dose.
Q2W, once every 2 weeks; Q3W, once every 3 weeks; Q4W, once every 4 weeks.