Evaluated globally in
2 clinical trials
BRUKINSA was assessed in a range of patients with ORR as the primary endpoint*1
A Phase 2, open-label, multicenter, single-arm trial in 86 patients with previously treated MCL following at least 1 prior therapy.1,2
2 analyses have been conducted
- Initial (18 months):
response assessed by IRC
using PET scans1,2 - Long term (35 months
exploratory analysis):
response assessed by
investigator using PET scans3
A Phase 1/2, open-label, multicenter, single-arm trial including 32 patients with previously treated MCL following at least 1 prior therapy.1,2
1 analysis has been conducted
- Initial (18 months):
response assessed by IRC
mostly using CT scans1,2
All responses were assessed according to the 2014 Lugano classification for non-Hodgkin lymphoma.1
| Baseline Patient Characteristics1,2 |
STUDY 206 (N=86) |
STUDY 003 (N=32) |
|---|---|---|
| Median age | 60.5 years (range:
|
70 years (range:
|
| Caucasian | 0% | 78% |
| Median time since diagnosis | 2.5 years | 4.5 years |
| Median prior anticancer regimens |
2
|
1
|
| Disease history Refractory MCL Extranodal disease Blastoid variant of MCL |
52% 71% 14% |
25% 78% 5% |
| Prior ASCT | 4% | 16% |
| Most common prior regimens CHOP-based Rituximab-based |
91% 74% |
59% 94% |
| MIPI score Low risk Intermediate risk High risk |
58% 29% 13% |
28% 41% 31% |
*In Study BGB-3111-206 (Study 206), patients were enrolled in China. In Study BGB-3111-AU-003 (Study 003), patients were enrolled in Australia, New Zealand, Europe, Asia, and the US. The primary endpoint was ORR as assessed by an IRC according to the 2014 Lugano classification for non-Hodgkin lymphoma. In Study 206, PET scans were required for response assessment. In Study 003, PET scans were not required for response assessment and the majority of patients were assessed mostly using CT scans.
ASCT=autologous stem cell transplant; CHOP=cyclophosphamide, doxorubicin, vincristine, prednisone; CT=computed tomography; IRC=independent review committee; MCL=mantle cell lymphoma; MIPI=mantle cell lymphoma international prognostic index; ORR=overall response rate; PET=positron emission tomography.
