Table 1.
Tisagenlecleucel cellular kinetic parameters in responding patients and nonresponding patients
| Parameter | Statistic | CR/CRi (N = 62) | NR (N = 8) | |
|---|---|---|---|---|
| AUC0–28d, copies/μg of DNA × days |
n Geometric mean (CV%) |
61 318,000 (177.8) |
6 156,000 (99.4) |
|
| Percent change (CR/CRi vs. NR) | 104% | |||
| Median (range) | 420,000 (21,000–2,740,000) | 129,000 (72,300–711,000) | ||
| Cmax, copies/μga |
n Geometric mean (CV%) |
61 34,700 (155.4) |
7 20,000 (71.6) |
|
| Percent change (CR/CRi vs. NR) | 74% | |||
| Median (range) | 44,800 (2,210–316,000) | 22,000 (9,700–57,700) | ||
| Tmax, days |
n Median (min–max) |
61 9.91 (0.00764–27.0) |
7 20.0 (0.0278–62.7) |
|
| T1/2, days |
n Geometric mean (CV%) |
54 16.8 (155.9) |
3 2.52 (171.9) |
|
| Tlast, days |
n Median (min–max) |
62 102 (17.8–380) |
8 27.8 (20.9–83.9) |
|
Abbreviations: AUC, area under the curve; Cmax, maximum (peak) expansion; CR, complete remission; CRi, complete remission with incomplete blood count recovery; CV%, coefficient of variation; max, maximum; min, minimum; NR, nonresponding response; T1/2, half-life; Tlast, time of last measurable in peripheral blood; Tmax, time to reach maximum (peak) peripheral blood tisagenlecleucel transgene level.
a
Seven patients had a Cmax determined from samples collected <1 day after infusion; these samples may represent the amount of tisagenlecleucel in the catheter rather than the amount of expanded tisagenlecleucel.