Table 3.
Population PK comparison of pola exposure (1.8 mg/kg q3w) at cycle 6 by treatment status (treatment-naïve vs. relapsed or refractory)
| Pola analyte | Parameter | Geometric mean (% CV) | GMR (90% CI) | |
|---|---|---|---|---|
| R/R (N = 380) | Treatment-naïve (N = 80) | |||
| acMMAE | AUC, ng day/mL | 2950 (21) | 2720 (15) | 0.92 (0.89–0.96) |
| Cmax, ng/mL | 734 (15) | 621 (17) | 0.85 (0.82–0.88) | |
| Unconjugated MMAE | AUC, ng day/mL | 20.9 (50) | 15.5 (42) | 0.74 (0.68–0.80) |
| Cmax, ng/mL | 1.93 (46) | 1.42 (37) | 0.74 (0.68–0.80) | |
All treatment-naïve B-NHL patients (N = 80) were from the current Study GO29044, who received pola co-administered with CHP chemotherapy. Relapsed/refractory B-NHL patients (N = 380) were from Studies DCS4968g (NCT01290549), GO27834 (NCT01691898), and GO29365 (NCT02257567), which included patients who received either single-agent pola, pola with R/G, or pola with R/G and bendamustine
acMMAE antibody-conjugated MMAE, AUC area under the curve, B-NHL B-cell non-Hodgkin lymphoma, CHP cyclophosphamide, doxorubicin, and prednisone, CI confidence interval, Cmax maximum concentration, CV coefficient of variation, G obinutuzumab, GMR geometric mean ratio, MMAE, monomethyl auristatin E, PK pharmacokinetic, pola polatuzumab vedotin, q3w every 3 weeks, R rituximab, R/R relapsed/refractory