POWERFUL AND
DURABLE RESPONSES

Adults with WM rapidly achieved high response rates regardless of line of therapy or mutation.

POWERFUL AND CONSISTENT RESPONSES
WITH BRUKINSA ACROSS ALL WM PATIENTS

While the primary endpoint of superiority did not reach statistical significance, numerically higher VGPR rates were achieved in the BRUKINSA treatment arm.1

Initial analysis (19 months)2

VGPR/CR/PR data for BRUKINSA® (zanubrutinib) vs ibrutinib

In all patients, median time to response (CR+VGPR+PR) was 2.8 months for the BRUKINSA arm and 2.9 months for the ibrutinib arm.3

The median follow-up time was 19.4 months.2

The prespecified efficacy outcome measure of VGPR/CR was assessed by IRC.1

*IWWM-6 criteria (Owen et al, 2013) requires complete resolution of extramedullary disease (EMD) if present at baseline for VGPR to be assessed. Modified IWWM-6 criteria (Treon, 2015) requires a reduction in EMD if present at baseline for VGPR to be assessed.4,5

†There were no CRs in either treatment arm.

CI=confidence interval; CR=complete response; IRC=independent review committee; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; PR=partial response; VGPR=very good partial response; WM=Waldenström’s macroglobulinemia.

SEE STUDY DESIGNS

CONSISTENT RESPONSES WITH BRUKINSA
REGARDLESS OF LINE OF THERAPY

Initial analysis (19 months)2

ORR data for BRUKINSA® (zanubrutinib) vs ibrutinib in treatment-naïve and relapsed/refractory subgroups

All subgroup analyses are exploratory and descriptive in nature.

The median follow-up time was 19.4 months.2

‡Responses were determined using modified IWWM-6 criteria.

§There were no CRs in either treatment arm.

CI=confidence interval; CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MR=minor response; ORR=overall response
rate; PR=partial response; VGPR=very good partial response.

CONSISTENT RESPONSES WITH BRUKINSA
REGARDLESS OF MUTATION

Initial analysis (19 and 18 months, respectively)2,6

Consistent response data for BRUKINSA® (zanubrutinib) in subgroups with MYD88 mutations

All analyses are exploratory and descriptive in nature.

The median follow-up time was 19.4 months for Cohort 1 and 17.9 months for Cohort 2.2,6

Responses were determined using modified IWWM-6 criteria.

#There were no CRs in either treatment arm.

CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MUT=mutated; PR=partial response; VGPR=very good partial response; WHIM=WHIM syndrome-like somatic mutation; WT=wild type.

RESPONSES CONTINUED OVER TIME REGARDLESS OF MUTATION

Long-term analysis (44 months and 43 months, respectively)7

Consistent response data over time for BRUKINSA® (zanubrutinib) in subgroups with MYD88 mutations

All analyses are exploratory and descriptive in nature.

The median follow-up time was 44.4 months for Cohort 1 and 42.9 months for Cohort 2.7

**Responses were determined using modified IWWM-6 criteria.

††In Cohort 2, 1 patient demonstrated a CR at 42.9-month follow-up.

CR=complete response; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MRR=major response rate; MUT=mutated; PR=partial response; VGPR=very good partial response; WT=wild type.

DURABLE DISEASE CONTROL
WITH BRUKINSA

Sustained responses in patients who achieved a response (CR+VGPR+PR)

Initial analysis (19 months)2

Event-free rate at 12 months for BRUKINSA® (zanbrutinib) vs ibrutinib

All subgroup analyses are exploratory and descriptive in nature.

Median duration of response (VGPR/CR) was not reached in either treatment arm.2

The median follow-up time was 19.4 months.2

At 2 years: Event-free duration of CR+VGPR for BRUKINSA was higher (90.6%; range 73.6%, 96.9%) vs ibrutinib (79.3%; range 53.5%, 91.8%)7

CI=confidence interval; CR=complete response; PR=partial response; VGPR=very good partial response.

CONSISTENT RESPONSES CONTINUE WITH BRUKINSA

STUDY 003: A PHASE 1/2 SUPPORTIVE STUDY8

A Phase 1/2, open-label, multicenter, single-arm trial including 77 patients with treatment-naïve and relapsed/refractory WM‡‡

ORR data from Study 003 (WM)

Data are consistent with results observed in ASPEN (Study 302) and the overall safety profile of BRUKINSA.8

Median follow-up time was 24 months in patients with treatment-naïve WM and 36 months in patients with R/R WM.8

‡‡ Assessed by IRC using modified IWWM-6 criteria.

§§There was 1 CR in the study.

CI=confidence interval; CR=complete response; IRC=independent review committee; IWWM-6=6th International Workshop on Waldenström’s Macroglobulinemia; MR=minor response; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory; VGPR=very good partial response; WM=Waldenström’s macroglobulinemia.

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BRUKINSA
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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% of patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

DRUG INTERACTIONS

CYP3A Inhibitors: When BRUKINSA is coadministered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • Waldenström’s macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
  • Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy

The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full Prescribing Information.

References: 1. BRUKINSA. Package insert. BeiGene USA, Inc.; 2025. 2. Tam CS, Opat S, D’Sa S, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-2050. 3. Data on file. BeiGene USA, Inc. 4. Owen RG, Kyle RA, Stone MJ, et al. Response assessment in Waldenström macroglobulinemia: update from the VIth International Workshop. Br J Haematol. 2013;160(2):171-176. 5. Treon SP. How I treat Waldenström macroglobulinemia. Blood. 2015;126(6):721-732. 6. Dimopoulos M, Sanz RG, Lee HP, et al. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial. Blood Adv. 2020;4(23):6009-6018. 7. Tam CS, Garcia-Sanz R, Opat S, et al. ASPEN: long-term follow-up results of a phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. Poster presented at: American Society of Clinical Oncology (ASCO) 2022 Annual Meeting; June 3-7, 2022. Abstract 7521. 8. Trotman J, Opat S, Gottlieb D, et al. Zanubrutinib for the treatment of patients with Waldenström macroglobulinemia: 3 years of follow-up. Blood. 2020;136(18):2027-2037.