Evaluated globally in
2 clinical trials

BRUKINSA was assessed in a range of patients with ORR as the primary endpoint*1

STUDY 206

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
Study 003 (MCL)

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: 34-75) 70 years (range: 42-86)
Caucasian 0% 78%
Median time since diagnosis 2.5 years 4.5 years
Median prior
anticancer regimens
2 (range: 1-4) 1 (range: 1-4)
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.

Powerful and
Sustained Responses
Efficacy
Established
Safety Profile
Safety
Personalized
Patient Support
Patient Support