Table 2.
Patient Characteristics
| Study 1 (n = 48) | Study 2 (n = 46) | Study 3 (n = 102) | Study 4 (n = 58) | Study 5 (n = 60) | All Patients (n = 314)a | |
|---|---|---|---|---|---|---|
| Age (years), median (range) | 36 (20–87) | 31.5 (12–82) | 31 (15–77) | 52 (14–76) | 36.5 (16–71) | 35 (12–87) |
| Female, n (%) | 19 (40) | 14 (30) | 54 (53) | 25 (43) | 24 (40) | 136 (43) |
| White, n (%) | 42 (88) | 38 (83) | 89 (87) | 48 (83) | 50 (83) | 267 (85) |
| Weight (kg), median (range) | 81.1 (45.9–154) | 79.6 (41.4–118) | 70.4 (44.6–168) | 69.8 (42.5–126) | 79.2 (41.5–165) | 74.8 (41.4–168) |
| Body surface area (m2), median (range) | 1.99 (1.43–2.69) | 1.96 (1.33–2.38) | 1.82 (1.43–2.86) | 1.81 (1.42–2.54) | 1.96 (1.35–2.64) | 1.86 (1.33–2.86) |
| Disease | ||||||
| HL, n (%) | 44 (92) | 40 (87) | 102 (100) | 0 (0) | 55 (92) | 241 (77) |
| sALCL, n (%) | 3 (6) | 5 (11) | 0 (0) | 56 (97) | 3 (5) | 67 (21) |
| Other, n (%) | 1 (2) | 1 (2) | 0 (0) | 2 (3) | 2 (3) | 6 (2) |
| Renal function | ||||||
| Creatinine clearance (mL/min), median (range)b | 115 (44–150) | 129 (22–150) | 124 (59–150) | 112 (28–150) | 126 (22–150) | 122 (22–150) |
| Hepatic function | ||||||
| Albumin (g/dL), median (range) | 3.7 (1.6–4.7) | 3.9 (2.4–4.8) | 3.6 (2.0–4.8) | 3.5 (1.8–4.6) | 3.8 (2.6–4.7) | 3.7 (1.6–4.8) |
| Aspartate aminotransferase (U/L), median (range) | 22 (10–55) | 24 (12–54) | 19 (9–109) | 22 (11–113) | 22 (9–73) | 21 (9–113) |
| Alanine aminotransferase (U/L), median (range) | 21.5 (5–98) | 29 (10–65) | 17 (4–80) | 20 (5–232) | 21 (6–115) | 21 (4–232) |
| Bilirubin (mg/dL), median (range) | 0.4 (0.2–1.0) | 0.4 (0.1–1.1) | 0.4 (0.2–1.3) | 0.4 (0.2–7.2) | 0.4 (0.1–1.0) | 0.4 (0.1–7.2) |
| Baseline tumor size (cm2), median (range) | 22.6 (2.83–180) | 16.7 (1.60–101) | 23.7 (1.50–276) | 14.0 (1.95–105) | NA | 20.3 (1.50–276)c |
| No. of concentrations | ||||||
| ADC | 1598 | 2079 | 2232 | 848 | 324 | 7081 |
| MMAE | 1698 | 2098 | 2241 | 840 | 575 | 7452 |
ADC, antibody‐drug conjugate; HL, Hodgkin lymphoma; MMAE, monomethyl auristatin E; sALCL, systemic anaplastic large‐cell lymphoma.
a
Includes 5 patients who were reenrolled with new patient numbers and retreated in study 1 (n = 3) or in study 2 (n = 2).
b
Capped at 150 mL/min.
c
n = 254; baseline tumor measurements were not collected in study 5.