TABLE 3.
Summary of acMMAE and unconjugated MMAE exposures at cycle 6 in the POLARIX PopPK analysis by ethnicity and region of enrollment.
| Exposure a | Statistics | Ethnicity | Region of enrollment | ||
|---|---|---|---|---|---|
| Asian (n = 84) | Non‐Asian (n = 345) | Within Asia d (n = 80) | Outside of Asia e (n = 349) | ||
| acMMAE AUC, ng/day/mL | Geometric mean (CV%) b | 2330 (12) | 2490 (14) | 2310 (12) | 2490 (14) |
| GMR c (90% CI) | 0.937 (0.913, 0.961) | 0.930 (0.906, 0.954) | |||
| acMMAE C max, ng/mL | Geometric mean (CV%) b | 596 (12) | 615 (15) | 592 (12) | 616 (15) |
| GMR c (90% CI) | 0.970 (0.945, 0.995) | 0.961 (0.937, 0.986) | |||
| Unconjugated MMAE AUC, ng/day/mL | Geometric mean (CV%) b | 11.2 (44) | 13.8 (49) | 11.1 (45) | 13.8 (49) |
| GMR c (90% CI) | 0.809 (0.739, 0.886) | 0.803 (0.731, 0.881) | |||
| Unconjugated MMAE C max, ng/mL | Geometric mean (CV%) b | 1.11 (38) | 1.34 (42) | 1.10 (38) | 1.33 (42) |
| GMR c (90% CI) | 0.833 (0.771, 0.900) | 0.827 (0.764, 0.896) | |||
Abbreviations: acMMAE, antibody‐conjugated monomethyl auristatin E; AUC, area under the concentration–time curve; C max, maximum concentration; CI, confidence interval; CV, coefficient of variation; GMR, geometric mean ratio; MMAE, monomethyl auristatin E; PopPK, population pharmacokinetics.
Individual exposures were computed for all patients following polatuzumab vedotin 1.8 mg/kg every 3 weeks for six cycles.
CV was computed as standard deviation of a log‐transformed variable.
GMR is defined as the mean ratio between Asian and non‐Asian patients, and between patients enrolled from Asia and those from outside of Asia.
Asian regions included China, Japan, (n = 54) South Korea (n = 17) and Taiwan (n = 9).
Non‐Asian regions included Western Europe (n = 159), North America (n = 117), Eastern Europe (n = 46), Pacific region (n = 21), and South/Central America (n = 6).