TABLE 6.
Treatment response by disease type in Chinese patients with relapsed/refractory B‐cell malignancies receiving zanubrutinib
| Response category, n (%) | CLL/SLL, (n = 9) | MCL, (n = 2) | WM, (n = 2) | FL, (n = 26) | MZL, (n = 5) | Total, (N = 44) |
|---|---|---|---|---|---|---|
| Best overall response | ||||||
| CR | 3 (33.3) | 1 (50.0) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 8 (18.2) |
| CRi | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| VGPR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| PR | 5 (55.6) | 0 (0.0) | 1 (50.0) | 8 (30.8) | 0 (0.0) | 14 (31.8) |
| PR‐L | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.3) |
| MR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Stable disease | 0 (0.0) | 1 (50.0) | 1 (50.0) | 7 (26.9) | 3 (60.0) | 12 (27.3) |
| PD | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 4 (9.1) |
| Discontinued prior to first assessment | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (11.5) | 2 (40.0) | 5 (11.4) |
| Overall response rate a | 9 (100.0) | 1 (50.0) | 1 (50.0) | 12 (46.2) | 0 (0.0) | 23 (52.3) |
| 95% CI | (66.4–100.0) | (1.3–98.7) | (1.3–98.7) | (26.6–66.6) | (0.0–52.2) | (36.7–67.5) |
| Partial response rate b | 8 (88.9) | 1 (50.0) | 1 (50.0) | 12 (46.2) | 0 (0.0) | 22 (50.0) |
| 95% CI | (51.8–99.7) | (1.3–98.7) | (1.3–98.7) | (26.6–66.6) | (0.0–52.2) | (34.6–65.4) |
| Complete response rate c | 3 (33.3) | 1 (50.0) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 8 (18.2) |
| 95% CI | (7.5–70.1) | (1.3–98.7) | (0.0–84.2) | (4.4–34.9) | (0.0–52.2) | (8.2–32.7) |
Note: 95% CIs were calculated using the Clopper–Pearson method.
Abbreviations: CI, confidence interval; CLL/SLL, chronic lymphocytic leukaemia/small lymphocytic lymphoma; CR, complete response; CRi, CR with incomplete marrow recovery; FL, follicular lymphoma; MCL, mantle cell lymphoma; MR, minor response; MZL, marginal zone lymphoma; PR, partial response; PR‐L, partial response with lymphocytosis; PD, progressive disease; NE, not estimable; VGPR, very good partial response; WM, Waldenström's macroglobulinaemia.
Overall response includes best overall response (of non‐stable disease, non‐PD, and non‐NE).
Partial response includes best overall response of PR or better (i.e., excluding PR‐L and MR).
Percentages are based on numbers of patients with best overall response of CR.