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
Rash 36 0 30.7 0.7
Diarrhea 23 0.8 23.5 1.9
Pneumonia 15 10 21.3 11.3
Musculoskeletal pain 14 3.4 29.8 2.8
Bruising 14 0 25.3 0.1
Constipation 13 0 16.2 0.4
Hypertension 12 3.4 11.7 5.2
Cough 12 0 22.9 0.1
Hemorrhage 11 3.4 35.4 3.4
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 (%)
Hematologic abnormalities
Neutrophils decreased 45 20
Platelets decreased 40 7
Hemoglobin decreased 27 6
Lymphocytosis 41 16
Chemistry abnormalities
Blood uric acid increased 29 2.6
ALT increased 28 0.9
Bilirubin increased 24 0.9

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
(N=847)1,2
Adverse Reaction Percent of Patients (N=847)
All Grades (%) Grade ≥3 (%)
Fatigue2 19.5 1.5
Headache2 12.9 0.6
Arthralgia2 10.7 0.9
Myalgia2 4.6 0.6
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

Dose reductions
due to ARs1
0.8
(1/118)
of patients
Discontinuation rate
due to ARs1
7
(8/118)
of patients

ALT=alanine aminotransferase; ARs=adverse reactions; BTK=Bruton's tyrosine kinase; MCL=mantle cell lymphoma; R/R=relapsed/refractory; TEAEs=treatment-emergent adverse events.

Powerful and
Sustained Responses
Efficacy
Flexible
Dosing
Dosing
Personalized
Patient Support
Patient Support