TABLE 1.
Demographics and disease characteristics of Chinese patients with relapsed/refractory B‐cell malignancies receiving zanubrutinib
| Part I | Part II | Total, (N = 44) | ||
|---|---|---|---|---|
| 160 mg BID, (n = 11) | 320 mg QD, (n = 10) | 160 mg BID, (n = 23) | ||
| Age, years | ||||
| Median | 54.0 | 55.0 | 46.0 | 52.0 |
| Min–max | 35–67 | 34–66 | 28–67 | 28–67 |
| Age group, n (%) | ||||
| <65years | 10 (90.9) | 9 (90.0) | 21 (91.3) | 40 (90.9) |
| ≥65years | 1 (9.1) | 1 (10.0) | 2 (8.7) | 4 (9.1) |
| Sex, n (%) | ||||
| Male | 9 (81.8) | 7 (70.0) | 8 (34.8) | 24 (54.5) |
| Female | 2 (18.2) | 3 (30.0) | 15 (65.2) | 20 (45.5) |
| ECOG performance status, n (%) | ||||
| 0 | 4 (36.4) | 5 (50.0) | 17 (73.9) | 26 (59.1) |
| 1 | 7 (63.6) | 5 (50.0) | 5 (21.7) | 17 (38.6) |
| 2 a | 0 (0.0) | 0 (0.0) | 1 (4.3) | 1 (2.3) |
| BMI, kg/m2 | ||||
| Median | 25.8 | 22.2 | 24.6 | 24.6 |
| Min–max | 21.5–30.7 | 20.6–32.8 | 17.7–31.6 | 17.7–32.8 |
| Diagnosis, n (%) | ||||
| CLL | 4 (36.4) | 3 (30.0) | 0 (0.0) | 7 (15.9) |
| SLL | 1(9.1) | 1(10.0) | 0 (0.0) | 2 (4.5) |
| WM | 1 (9.1) | 1 (10.0) | 0 (0.0) | 2 (4.5) |
| NHL | 5 (54.5) | 5 (60.0) | 23 (100.0) | 33 (79.5) |
| FL | 3 | 3 | 20 | 26 |
| MZL | 2 | 0 | 3 | 5 |
| MCL | 0 | 2 | 0 | 2 |
| Time from initial diagnosis to study entry, years | ||||
| Median | 4.7 | 2.4 | 2.3 | 2.8 |
| Min–max | 1.1–8.2 | 0.5–10.1 | 0.8–20.1 | 0.5–20.1 |
| Bone marrow biopsy infiltration of abnormal lymphocytes, n (%) | ||||
| Yes | 5 (45.5) | 6 (60.0) | 9 (39.1) | 20 (45.5) |
| No | 6 (54.5) | 4 (40.0) | 14 (60.9) | 24 (54.5) |
Note: Percentages are based on n, number of patients who received ≥1 dose of zanubrutinib.
Abbreviations: BID, twice daily; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; CLL, chronic lymphocytic leukaemia; FL, follicular lymphoma; max, maximum; MCL, mantle cell lymphoma; min, minimum; MZL, marginal zone lymphoma; NHL, non‐Hodgkin lymphoma; QD, once daily; SLL, small lymphocytic lymphoma; WM, Waldenström's macroglobulinaemia.
a
One patient had an ECOG performance status score of 1 during screening but it declines to a score of 2 on cycle 1 day 1.