Table 3.
Zanubrutinib exposure and treatment status
| N = 779 | |
|---|---|
| Months, median (25th-75th percentile) | 25.8 (11-32) |
| <24, n (%) | 353 (45) |
| 24 to <36, n (%) | 301 (39) |
| 36 to >48, n (%) | 82 (11) |
| ≥48, n (%) | 43 (6) |
| Exposure by age group, y | |
| <65 | 27.6 (11-32) |
| 65 to <75 | 25.1 (11-31) |
| ≥75 | 23 (12-31) |
| Relative treatment intensity, median % (25th-75th percentile) * | |
| Overall | 99 (96-100) |
| 160 mg BID† | 99 (96-100) |
| 320 mg QD† | 99 (97-100) |
| Dose reductions, n (%) | |
| All patients with at least 1 dose reduction‡ | 66 (8) |
| Number of dose reductions | |
| 1 | 47 (6) |
| 2 | 13 (2) |
| ≥3 | 6 (1) |
| Treatment interruptions, n (%) | |
| All patients with at least 1 treatment interruption§ | 282 (38) |
| Number of treatment interruptions | |
| 1 | 173 (24) |
| 2 | 68 (9) |
| ≥3 | 41 (6) |
| Treatment discontinuations, n (%) | |
| Patients discontinued from treatment | 335 (43) |
| Progressive disease | 208 (27) |
| Adverse event | 80 (10) |
| Withdrawal by patient | 18 (2) |
| Investigator’s discretion | 16 (2) |
| Other | 11 (1) |
| Protocol deviation | 1 (0.1) |
| Patients remaining on treatment | 444 (57) |
*
Defined as the actual cumulative dose divided by the intended cumulative dose over the duration of the treatment period.
†
Based on the number of patients assigned to each dosing regimen at treatment onset.
‡
Includes all patients with at least 1 dose reduction. Fifty-three patients had 1 or more dose reduction for AEs; for the remaining, dose reduction was based on investigator discretion or other reason.
§
Includes treatment interruptions from AEs only for all studies except BGB-3111-1002 (n = 735).