Table 3.
Comparison of pCC Cycle 6 exposures by race and region based on the popPK model
| PK parameter | Statistic | Race | Region | ||
|---|---|---|---|---|---|
| Non-Asian (N = 442) | Asian (N = 18) | Non-Asia (N = 450) | Asia (N = 10) | ||
| acMMAE | |||||
| AUCinf, ng·day/mL | GM (%CV) | 2910 (21%) | 2870 (12%) | 2910 (21%) | 2800 (12%) |
| GMR (90% CI) | 0.988 (0.94–1.04) | 0.961 (0.897–1.03) | |||
| Cmax, ng/mL | GM (%CV) | 734 (15%) | 733 (13%) | 735 (15%) | 691 (13%) |
| GMR (90% CI) | 0.998 (0.944–1.05) | 0.939 (0.87–1.01) | |||
| Unconjugated MMAE | |||||
| AUCinf, ng·day/mL | GM (%CV) | 21.4 (49%) | 17.4 (40%) | 21.3 (50%) | 16 (25%) |
| GMR (90% CI) | 0.814 (0.688–0.963) | 0.75 (0.647–0.87) | |||
| Cmax, ng/mL | GM (%CV) | 1.98 (45%) | 1.64 (38%) | 1.98 (45%) | 1.52 (23%) |
| GMR (90% CI) | 0.831 (0.708–0.975) | 0.768 (0.669–0.881) | |||
acMMAE antibody-conjugated monomethyl auristatin E, AUCinf area under the concentration–time curve from time 0 to infinity, CI confidence interval, Cmax maximum concentration observed, CV coefficient of variation, GM geometric mean, GMR geometric mean ratio, MMAE monomethyl auristatin E, pCC partial covariate-corrected, PK pharmacokinetic, popPK population PK