TABLE 2.
Mean (standard deviation) concentrations of acMMAE, total antibody and unconjugated MMAE by region measured in patients from the POLARIX PK‐evaluable population following polatuzumab vedotin at 1.8 mg/kg as part of the Pola‐R‐CHP regimen.
| Region of enrollment | |||
|---|---|---|---|
| Asia | Non‐Asia | All | |
| Mean acMMAE concentration, ng/mL | |||
| Cycle 1 day 1 | |||
| C max 30 min postdose (SD) | 597 (104) | 604 (162) | 603 (153) |
| n | 68 | 294 | 362 |
| Cycle 4 day 1 | |||
| C trough predose (SD) | 18.8 (23.7) | 18.0 (6.6) | 18.2 (12.0) |
| n | 78 | 324 | 402 |
| C max 30 min postdose (SD) | 621 (110) | 666 (186) | 657 (175) |
| n | 68 | 292 | 360 |
| Mean total antibody concentration, μg/mL | |||
| Cycle 1 day 1 | |||
| C trough predose (SD) | NR (NR) | NR (NR) | NR (NR) |
| n | 78 | 340 | 418 |
| C max 30 min postdose (SD) | 35.8 (7.7) | 36.2 (11.7) | 36.1 (11.0) |
| n | 76 | 319 | 395 |
| Cycle 4 day 1 | |||
| C trough predose (SD) | 5.1 (2.4) | 5.5 (3.4) | 5.4 (3.2) |
| n | 77 | 330 | 407 |
| C max 30 min postdose (SD) | 42.1 (10.2) | 44.9 (15.3) | 44.4 (14.5) |
| n | 77 | 321 | 398 |
| Mean unconjugated MMAE concentration, ng/mL | |||
| Cycle 1 day 1 | |||
| C max30 min postdose (SD) | 0.401 (0.2) | 0.429 (0.4) | 0.424 (0.3) |
| n | 80 | 323 | 403 |
| Cycle 4 day 1 | |||
| C trough predose (SD) | 0.120 (0.1) | 0.150 (0.1) | 0.144 (0.1) |
| n | 79 | 327 | 406 |
| C max 30 min postdose (SD) | 0.194 (0.1) | 0.229 (0.1) | 0.222 (0.1) |
| n | 79 | 319 | 398 |
Note: Values are rounded to 1 decimal point. C trough values were measured in samples taken predose and C max values were measured in samples taken 30 min postdose. The number of evaluable patients for each PK variable ranged between 68 and 80 for patients from Asia, 292–340 for patients from outside of Asia, and 360–418 for patients from all regions.
Abbreviations: acMMAE, antibody‐conjugated monomethyl auristatin E; C max, maximum concentration; C trough, last concentration prior to dosing; MMAE, monomethyl auristatin E; NR, not reached; PK, pharmacokinetic; Pola‐R‐CHP, polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone; SD, standard deviation.