The Safety
of Brukinsa

Overall incidence of adverse reactions (ARs)1,2



Adverse
Reactions1,2
ARs in ≥10% of patients with WM (Cohort 1) Pooled data: ARs in patients with hematologic malignancies
BRUKINSA (n=101) Ibrutinib (n=98) BRUKINSA (N=1550)*
All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades ≥3 (%)
Upper respiratory tract infection 44 0 40 2 39 2
Pneumonia 12 4 26 10 20 11
Urinary tract infection 11 0 13 2 13 2
Diarrhea 22 3 34 2 19 2
Nausea 18 0 13 1 11 0.2
Constipation 16 0 7 0 13 0.3
Vomiting 12 0 14 1 7 0.3
Fatigue 31 1 25 1 17 1
Pyrexia 16 4 13 2 10 0.8
Edema peripheral 12 0 20 0 4 0.2
Bruising 20 0 34 0 23 0.1
Rash 29 0 32 0 28 0.9
Pruritus 11 1 6 0 7 0.1
Musculoskeletal pain 45 9 39 1 30 2
Muscle spasms 10 0 28 1 5 0.1
Headache 18 1 14 1 11 0.4
Dizziness 13 1 12 0 11 0.3
Cough 16 0 18 0 19 0.1
Dyspnea 14 0 7 0 8 0.5
Hemorrhage 42 4 43 9 30 4
Hypertension 14 9 19 14 14 7

Safety in WM consistent with established BRUKINSA
profile across B-cell malignancies1,2

The median follow-up time for Cohort 1 was 19.4 months.3


BRUKINSA had lower rates of:

Hypertension3

  • Ibrutinib patients experienced nearly 2-fold higher incidence rate of hypertension on an exposure-adjusted basis (BRUKINSA vs ibrutinib: 0.7% vs 1.2%, respectively)

Major hemorrhage3

  • Ibrutinib patients experienced nearly 2-fold higher incidence rate of major hemorrhage on an exposure-adjusted basis (BRUKINSA vs ibrutinib: 0.3% vs 0.6%, respectively)

*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.3


WM=Waldenström’s macroglobulinemia.


INCIDENCE OF LABORATORY ABNORMALITIES

Select laboratory abnormalities (≥20%) that worsened
from baseline in Cohort 1

Laboratory Abnormality1 BRUKINSA Ibrutinib
All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%)
Hematologic abnormalities
Neutrophils decreased 50 24 34 9
Platelets decreased 35 8 39 5
Hemoglobin decreased 20 7 20 7
Chemistry abnormalities
Bilirubin increased 12 1.0 33 1.0
Calcium decreased 27 2.0 26 0
Creatinine increased 31 1.0 21 1.0
Glucose increased§ 45 2.3 33 2.3
Potassium increased 24 2.0 12 0
Urate increased 16 3.2 34 6
Phosphate decreased 20 3.1 18 0


BRUKINSA had a higher rate of neutropenia (BRUKINSA=29.7% vs ibrutinib=13.3%), not associated with increased infection (BRUKINSA=66.3% vs ibrutinib=67.3%)3


Based on laboratory measurements.

The denominator used to calculate the rate varied from 86 to 101 based on the number of
patients with a baseline value and at least 1 post-treatment value.

§Patients on study were not required to fast for lab tests.



INCIDENCE OF ATRIAL FIBRILLATION/FLUTTER


Adverse Event3 All Grades
n (%)
Grade ≥3
n (%)
BRUKINSA
(n=101)
Ibrutinib
(n=98)
BRUKINSA
(n=101)
Ibrutinib
(n=98)
Atrial fibrillation/flutter 2 (2) 15 (15) 0 (0) 4 (4)

BRUKINSA HAD LOWER RATES OF:

Atrial fibrillation/flutter2,3


  • Ibrutinib patients experienced nearly 10-fold higher incidence of atrial fibrillation/flutter on an exposure-adjusted basis (BRUKINSA vs ibrutinib: 0.1% vs 1.0%, respectively)
  • No incidences of Grade ≥3 atrial fibrillation or flutter in patients who received BRUKINSA

Low rate of atrial fibrillation/flutter
and hypertension with BRUKINSA


Initial analysis (19 months)3



Brukinsa

Adverse event trends

Incidence of atrial fibrillation/flutter and hypertension were lower in patients receiving BRUKINSA than in patients taking ibrutinib.4

In a ~4-year follow-up consistent with the primary analysis, BRUKINSA continued to demonstrate lower rates of atrial fibrillation/flutter and hypertension4



The median follow-up time was 19.4 months for Cohort 1.3



ADVERSE REACTIONS OF INTEREST AND THEIR PREVALENCE OVER TIME4


Long-term analysis (44 months)4




Dose reductions and discontinuation rate
DUE TO ADVERSE EVENTS (AEs) in ASPEN (Study 302)3


Initial analysis (19 months)3


Dose reductions
due to AEs
BRUKINSACohort 1 (n=101)
14
of patients
Ibrutinib(n=98)
23
of patients
Discontinuation rate
due to AEs
BRUKINSA Cohort 1 (n=101)
4
of patients
Ibrutinib(n=98)
9
of patients


In a ~4-year follow-up consistent with the primary analysis, fewer AEs leading to treatment discontinuation and dose reductions occurred with BRUKINSA4

Dr Anthony Nguyen discusses the safety profile of BRUKINSA vs ibrutinib in WM

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