TABLE 1.
Summary of studies included in the analysis
| Study | Study description | PK sample collection a | Acalabrutinib n with PK data (all doses/100 mg BID b ) | ACP‐5862 n with PK data a (all doses/100 mg BID b ) |
|---|---|---|---|---|
| ACE‐CL‐001 4 , 26 (NCT02029443) | Phase 1/2 study in patients with R/R or previously untreated CLL, Richter's transformation, or PLL | Cycle 1: d 1, 8, 15, 22 and 28 | 161/130 | 18/18 |
| ACE‐CL‐003 27 (NCT02296918) | Phase 1b study in patients with R/R CLL | Cycle 1: d 1 | 8/8 | 0/0 |
| ACE‐CL‐007 8 (NCT02475681) | Phase 3 study in patients with previously untreated CLL | Cycles 1 and 2: d 1 | 273/263 | 274/264 |
| ACE‐LY‐002 28 (NCT02112526) | Phase 1b study in patients with R/R de novo activated B‐cell subtype of DLBCL |
Cycle 1: d 1, 8, 15 and 22 Cycle 2: d 1 |
15/15 | 0/0 |
| ACE‐LY‐003 29 (NCT02180711) | Phase 1b study of acalabrutinib alone or in combination with rituximab in patients with FL | Cycle 1: d 1, 8, 15, 22 and 28 | 7/7 | 0/0 |
| ACE‐LY‐004 6 (NCT02213926) | Phase 2 study in patients with MCL | Cycle 1: d 1, 8, 15, 22 and 28 | 45/45 | 0/0 |
| ACE‐MY‐001 (NCT02211014) | Phase 1b study of acalabrutinib alone or in combination with dexamethasone in patients with MM | Cycle 1: d 1, 8, 15, 22 and 28 | 13/13 | 0/0 |
| ACE‐WM‐001 30 (NCT02180724) | Phase 1/2 in patients with WM | Cycle 1: d 1, 8, 15, 22 and 28 | 50/49 | 0/0 |
| Total | 572/530 | 292/282 |
BID, twice daily; CLL, chronic lymphocytic leukaemia; DLBCL, diffuse large B‐cell lymphoma; FL, follicular lymphoma; MCL, mantle cell lymphoma; MM, multiple myeloma; PK, pharmacokinetic; PLL, prolymphocytic leukaemia; R/R, relapsed/refractory; WM, Waldenström macroglobulinemia.
a
For patients without observed acalabrutinib or ACP‐5862 concentrations, exposures were predicted based on the typical population PK parameter values.
b
Dose is based on the most prevalent dose/dosing regimen administered to individuals for the duration of the clinical study.