The Safety of Brukinsa
DEMONSTRATED SAFETY PROFILE IN R/R MCL
|Combined adverse reactions (ARs) in ≥10% of patients with MCL (N=118)1||Pooled data: ARs in patients with hematologic malignancies (N=847)*1,2|
|Adverse Reaction||All Grades (%)||Grade ≥3 (%)||All Grades (%)||Grade ≥3 (%)|
|Upper respiratory tract infection||39||0||46.5||3.3|
|Urinary tract infection||11||0.8||16.2||2.6|
|Select Laboratory Abnormalities† (≥20%) in Patients With MCL in Studies BGB-3111-206 and BGB-3111-AU-0031|
|Laboratory Parameter||Percent of Patients (N=118)|
|All Grades (%)||Grade 3 or 4 (%)|
|Blood uric acid increased||29||2.6|
No patients discontinued due to neutropenia and 2 patients had febrile neutropenia. Patients on study received growth factor support as needed.3
|ars of special interest in
the pooled safety population
|Adverse Reaction||Percent of Patients (N=847)|
|All Grades (%)||Grade ≥3 (%)|
|Atrial ﬁbrillation and atrial ﬂutter1||3.2||1.1|
The most common ARs, including laboratory abnormalities (≥30%; pooled safety population N=847), included neutrophil count decreased (54%), upper respiratory tract infection (47%), platelet count decreased (41%), hemorrhage (35%), lymphocyte count decreased (31%), rash (31%), and musculoskeletal pain (30%).1
*Chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, hairy cell leukemia, diffuse large B-cell lymphoma, and Richter’s transformation.2
†Based on laboratory measurements.
‡Asymptomatic lymphocytosis is a known effect of BTK inhibition.
Long-term safety analysis IN MCL
The overall safety profile was unchanged at 35 months.1,4
Most ARs occurred during the early stage of BRUKINSA treatment. There were no additional cases of:
- Atrial fibrillation
- Atrial flutter
- Grade ≥3 cardiac ARs
With 35.3 months of follow-up, the most common (≥20%) TEAEs observed were decreased neutrophil count (46.5%), upper respiratory tract infection (38.4%), rash (36.0%), decreased white blood cell count (33.7%), and decreased platelet count (32.6%); most were Grade 1/2 events.
The prevalence of neutropenia with any grade or Grade ≥3 decreased after the first year; no Grade ≥3 neutropenia occurred after 18 months.
No new TEAEs led to treatment discontinuation or dose reduction during the longer follow-up time.
Dose reduction and treatment
discontinuation rates IN MCL1
due to ARs1
due to ARs1
ALT=alanine aminotransferase; ARs=adverse reactions; BTK=Bruton's tyrosine kinase; MCL=mantle cell lymphoma; R/R=relapsed/refractory; TEAEs=treatment-emergent adverse events.