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 Abnormality†1 | 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#
due to ARs1
due to ARs1
#Dose reduction and discontinuation rates represent combined data from MAGNOLIA (Study 214) and Study 003.
