Evaluated globally in
2 clinical trials

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

MAGNOLIA (STUDY 214)

A Phase 2, open-label, multicenter, single-arm trial in 68 patients with relapsed or refractory MZL following at least 1 prior therapy.*1,2

Study 003 (MZL)

A Phase 1/2, open-label, multicenter, single-arm trial including 20 patients with relapsed or refractory MZL following at least 1 prior therapy.†1,3


The primary endpoint of ORR was assessed by
an IRC using 2014 Lugano criteria.1

Patient demographics1,4,5

Baseline Patient Characteristics (Cohort 1) MAGNOLIA (Study 214)
(N=66)
Study 003§
(N=20)
Median age 70 years (range: 37-85) 70 years (range: 52-85)
Age >75 years 28% 20%
Male 55% 50%
Race
Caucasian 60% 75%
Asian 19% 20%
Other/Not reported 17% 5%
ECOG
0-1 88% 95%
2 7% 10%

Comorbidities4,5

Baseline Patient Characteristics (Cohort 1) MAGNOLIA (Study 214)
(N=66)
Study 003
(N=20)
Atrial fibrillation and atrial flutter 12% 5%
Hypertension 31% 25%

Disease history1,4-6

Baseline Patient Characteristics (Cohort 1) MAGNOLIA (Study 214)
(N=66)
Study 003
(N=20)
Median time since diagnosis 5 years 6 years
Median prior regimens 2 (range: 1-6) 2 (range: 1-5)
MZL subtype
Extranodal/MALT 38% 45%
Nodal 38% 25%
Splenic 18% 30%
Unknown 6% 0%
Site of disease for extranodal/MALT subtype
Gastric 8% N/A
Nongastric 73% N/A
Disease
Relapsed disease 65% 75%
Refractory disease 32% 20%
Bone marrow involvement 43% 70%
Bulky disease 37% 100%
Extranodal disease 78% 100%
Prior ASCT 6% 0%
Prior radiotherapy 22% 5%
Most common prior regimens
Rituximab-based 88% 95%
Alkylating agents 85% 80% (cyclophosphamide)

*In MAGNOLIA (Study 214), PET scans were required for response assessment. Two patients in the study were not evaluable for efficacy due to central confirmation of MZL transformation to diffuse large B-cell lymphoma but were included for safety evaluation.

In Study 003, PET scans were not required for response assessment and the majority of patients were assessed mostly using CT scans.

In Study BGB-3111-214 MAGNOLIA (Study 214), patients were enrolled in Australia, China, Italy, United Kingdom, New Zealand, United States, France, Czech Republic, and South Korea.

§In Study BGB-3111-AU-003 (Study 003), patients were enrolled in Australia, New Zealand, Europe, Asia, and the US.


ASCT=autologous stem cell transplant; CT=computed tomography; ECOG=Eastern Cooperative Oncology Group; IRC=independent review committee; MALT=mucosa-associated lymphoid tissue; MZL=marginal zone lymphoma; N/A=not available; ORR=overall response rate; PET=positron emission tomography.

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