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SEE THE LONG-TERM DATA ACROSS LINES OF THERAPY 

BRUKINSA: MAKE A
POWERFUL IMPACT
IN CLL

BRUKINSA was designed to meet the challenges of BTK inhibition, including in adult patients with CLL1

SUPERIOR EFFICACY ACROSS LINES OF THERAPY1-3
Superior PFS vs BR with consistent benefit in the largest prospective study of 1L patients with del17(p)1,3

Median follow-up: 26.2 months for Cohort 1 and 30.5 months for Cohort 2 at the initial analysis; 43.7 months for Cohort 1 and 47.9 months for Cohort 2 at the long-term follow-up.3,4

*All analyses are exploratory and descriptive in nature.

The only BTKi with superior efficacy vs ibrutinib, regardless of mutation status1,2

Median follow-up: 31 months for PFS and 24.7 months for ORR at the initial analysis; 39 months for PFS and ORR at the long-term follow-up.1,5,6

SEQUOIA was a global Phase 3, randomized, open-label, multicenter trial evaluating BRUKINSA vs BR in 479 patients with previously untreated CLL/SLL without del(17p)/TP53. 110 patients with del(17p) were evaluated in a separate single-arm cohort and received BRUKINSA only. The primary endpoint was PFS per IRC in the ITT population in the BRUKINSA arm and the BR arm, with minimum 2-sided alpha of 0.05 for superiority.1,3

ALPINE was a global Phase 3, randomized, open-label, multicenter trial evaluating BRUKINSA vs ibrutinib in 652 patients with relapsed/refractory CLL/SLL who received ≥1 prior systemic therapy. Statistical analysis for PFS and ORR were initially conducted for noninferiority. When noninferiority was met, superiority was tested.1,2

1L=first line; 2L=second line; afib=atrial fibrillation; BR=bendamustine+rituximab; BTK=Bruton's tyrosine kinase; CI=confidence interval; CLL=chronic lymphocytic leukemia; HR=hazard ratio; IRC=independent review committee; ITT=intent to treat; ORR=overall response rate; PFS=progression-free survival; SLL=small lymphocytic lymphoma.

VIEW LONG-TERM EFFICACY DATA
CONSISTENTLY LOW RATES OF AFIB/FLUTTER AND DISCONTINUATION ACROSS TRIALS

CONSISTENCY IN 2 GLOBAL PHASE 3 TRIALS

Median duration of treatment: 26.1 months for BRUKINSA and 5.6 months for BR in Cohort 1; 30.0 months for BRUKINSA in Cohort 2.3

Median duration of treatment: 28.4 months for BRUKINSA and 24.3 months for ibrutinib.2

1L=first line; 2L=second line; AE=adverse event; afib=atrial fibrillation; BR=bendamustine+rituximab.

VIEW LONG-TERM SAFETY DATA

Dr Anthony Nguyen discusses how BRUKINSA has benefited his patients

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NCCN

PREFERRED

Zanubrutinib (BRUKINSA®) is a National Comprehensive Cancer Network® (NCCN®) preferred treatment option for patients with CLL7:

Without del(17p)/TP53
First-line: Category 1
Second-line: Category 1

With del(17p)/TP53
First-line: Category 2A
Second-line: Category 1

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 11, 2024. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.

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IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking BRUKINSA?

Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:

  • have bleeding problems.
  • have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
  • have an infection.
  • have or had heart rhythm problems.
  • have high blood pressure.
  • have liver problems, including a history of hepatitis B virus (HBV) infection.
  • are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.
    • Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
    • Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
  • are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

  • Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    • blood in your stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or you cannot control
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • increased bruising
    • dizziness
    • weakness
    • confusion
    • change in speech
    • headache that lasts a long time
  • Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
  • Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
    • your heartbeat is fast or irregular
    • feel lightheaded or dizzy
    • pass out (faint)
    • shortness of breath
    • chest discomfort

The most common side effects of BRUKINSA include:

  • decreased white blood cell count
  • decreased platelet count
  • upper respiratory tract infection
  • bleeding
  • muscle, bone, or joint pain

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults 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 treatment for their cancer.
  • Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
  • Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.

It is not known if BRUKINSA is safe and effective in children.

Please see full Prescribing Information including Patient Information.

References: 1. BRUKINSA. Package insert. BeiGene USA, Inc.; 2024. 2. Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388(4):319-332. 3. Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. 4. Munir T, Shadman M, Robak T, et al. Zanubrutinib (zanu) vs bendamustine + rituximab (BR) in patients (pts) with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): extended follow-up of the SEQUOIA study. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-15, 2023. Abstract P639. 5. Brown JR, Eichhorst B, Lamanna N, et al. Extended follow-up of ALPINE randomized phase 3 study confirms sustained superior progression-free survival of zanubrutinib versus ibrutinib for treatment of relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (R/R CLL/SLL). Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12, 2023. 6. Data on file. BeiGene USA, Inc. 7. National Comprehensive Cancer Network. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2024.

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