Individual clinical trial details for integrated safety analysis*
| Clinical trial . | Study no. . | Phase . | Zanubrutinib dose (n) . | B-cell malignancies . | Patients, no. . | Enrollment dates . |
|---|---|---|---|---|---|---|
| NCT0234312 | AU-003 (first in humans) | 1/2 | 160 mg BID (n = 278) 40 mg QD (n = 3)† 80 mg QD (n = 4)† 160 mg QD (n = 5)† 320 mg QD (n = 95) | CLL/SLL, DLBCL, FL, HCL, MCL, MZL, RT, or WM | 385 | August 2014-June 2019 |
| NCT03189524 | 1002 | 1 | 160 mg BID (n = 34) 320 mg QD (n = 10) | CLL/SLL, MCL, WM/LPL, FL, MZL, HCL, or non-GCB DLBCL | 44 | July 2016-November 2017 |
| NCT03206918 | 205 | 2 | 160 mg BID (n = 91) | CLL/SLL | 91 | March-December 2017 |
| NCT03206970 | 206 | 2 | 160 mg BID (n = 86) | MCL | 86 | March-September 2017 |
| NCT03332173 | 210 | 2 | 160 mg BID (n = 44) | WM | 44 | August 2017-May 2018 |
| NCT03053440 | 302‡ | 3 | 160 mg BID (n = 129) | WM | 129 | January 2017-July 2018 |
| Total | 779 |
| Clinical trial . | Study no. . | Phase . | Zanubrutinib dose (n) . | B-cell malignancies . | Patients, no. . | Enrollment dates . |
|---|---|---|---|---|---|---|
| NCT0234312 | AU-003 (first in humans) | 1/2 | 160 mg BID (n = 278) 40 mg QD (n = 3)† 80 mg QD (n = 4)† 160 mg QD (n = 5)† 320 mg QD (n = 95) | CLL/SLL, DLBCL, FL, HCL, MCL, MZL, RT, or WM | 385 | August 2014-June 2019 |
| NCT03189524 | 1002 | 1 | 160 mg BID (n = 34) 320 mg QD (n = 10) | CLL/SLL, MCL, WM/LPL, FL, MZL, HCL, or non-GCB DLBCL | 44 | July 2016-November 2017 |
| NCT03206918 | 205 | 2 | 160 mg BID (n = 91) | CLL/SLL | 91 | March-December 2017 |
| NCT03206970 | 206 | 2 | 160 mg BID (n = 86) | MCL | 86 | March-September 2017 |
| NCT03332173 | 210 | 2 | 160 mg BID (n = 44) | WM | 44 | August 2017-May 2018 |
| NCT03053440 | 302‡ | 3 | 160 mg BID (n = 129) | WM | 129 | January 2017-July 2018 |
| Total | 779 |
BID, twice daily; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; HCL, hairy cell leukemia; LPL, lymphoplasmacytic lymphoma; MCL, mast-cell lymphoma; MZL, marginal zone lymphoma; non-GCB, non-germinal center B-cell type; QD, every day; RT, Richter transformation.
Data cutoff date: 31 March 2020 for all studies.
Patients assigned to daily doses of 40 to 160 mg were enrolled to the dose escalation component (part 1) of AU-003.
Study BGB-3111 302 includes a randomized comparison of zanubrutinib (n = 101) and ibrutinib (n = 98) in patients with R/R WM, all with MYD88MUT disease,11 as well as a single-arm, substudy of WM patients with MYD88WT disease treated with zanubrutinib (n = 28).16