Evaluated globally in
2 clinical trials
BRUKINSA was assessed in a range of patients with ORR as the primary endpoint
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
A Phase 1/2, open-label, multicenter, single-arm trial including 20 patients with relapsed or refractory MZL following at least
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
|
|
|---|---|---|
| Median age | 70 years
|
70 years
|
| 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
|
|
|---|---|---|
| Atrial fibrillation and atrial flutter | 12% | 5% |
| Hypertension | 31% | 25% |
Disease history1,4-6
| Baseline Patient Characteristics (Cohort 1) | MAGNOLIA
|
|
|---|---|---|
| Median time since diagnosis | 5 years | 6 years |
| Median prior regimens | 2
|
2
|
| 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.
