The Safety of Brukinsa

SAFETY IN R/R MZL CONSISTENT
WITH ESTABLISHED PROFILE ACROSS
B-CELL MALIGNANCIES1

Safety in MZL:
Combined Adverse Reactions (ARs) in ≥10% of Patients
With R/R MZL (N=88)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 26 3.4 46.5 3.3
Urinary tract infection 11 2.3 16.2 2.6
Pneumonia 10 6 21.3 11.3
Diarrhea 25 3.4 23.5 1.9
Abdominal pain 14 2.3 10.9 0.9
Nausea 13 0 11.6 0.4
Bruising 24 0 25.3 0.1
Rash 21 0 30.7 0.7
Musculoskeletal pain 27 1.1 29.8 2.8
Hemorrhage 23 1.1 35.4 3.4
Fatigue 21 2.3 19.5 1.5
Cough 10 0 22.9 0.1

No cases of hemorrhage led to treatment discontinuation.2

*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

Select Laboratory Abnormalities (≥20%) That Worsened
From Baseline in Patients With MZL
Laboratory Abnormality1 BRUKINSA
All Grades (%) Grade 3 or 4 (%)
Hematologic abnormalities
Neutrophils decreased 43 15
Platelets decreased 33 10
Lymphocytes decreased 32 8
Hemoglobin decreased 26 6
Chemistry abnormalities
Glucose increased 54 4.6
Creatinine increased 34 1.1
Phosphate decreased 27 2.3
Calcium decreased 23 0
ALT increased 22 1.1

Neutropenia did not result in treatment discontinuation or dose reduction, and no patients had febrile neutropenia.2

Patients on study received growth factor support as needed.2

The denominator used to calculate the rate varied from 87 to 88 based on the number of patients with a baseline value and at least one post-treatment value.

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


ARs of Special Interest in Patients With Hematologic Malignancies (N=847)§1,2
Adverse Reaction All Grades (%) Grade ≥3 (%)
Hypertension 11.7 5.2
Atrial fibrillation and atrial flutter 3.2 1.1

The most common adverse reactions, including laboratory abnormalities, in ≥30% of patients who received BRUKINSA (N=847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%), and musculoskeletal pain (30%).

§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

Low rates of ARs of SPECIAL INTEREST in R/R MZL
(MAGNOLIA STUDY 214, n=68)2

Atrial fibrillation

  • 1 patient experienced atrial fibrillation and 1 patient experienced atrial flutter

Hypertension

  • 1 patient experienced hypertension

Atrial fibrillation resolved 1 day after onset and patient had a history of Grade 1 atrial fibrillation.


ALT=alanine aminotransferase; ARs=adverse reactions; MZL=marginal zone lymphoma; R/R=relapsed/refractory.

COMBINED Dose reduction and treatment
discontinuation rates IN R/R MZL#

Dose reductions
due to ARs1
2.3
(2/88)
of patients
Discontinuation rate
due to ARs1
6
(5/88)
of patients

#Dose reduction and discontinuation rates represent combined data from MAGNOLIA (Study 214) and Study 003.

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