Head-to-head study designs for BRUKINSA® (zanubrutinib) in CLL/SLL.

BRUKINSA patients can call the myBeiGene^® patient support program to talk to a dedicated nurse: 1-833-BEIGENE (1-833-234-4363)

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

EFFICACY DEMONSTRATED ACROSS LINES OF THERAPY

EFFICACY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENT EFFICACY IN AN ADDITIONAL PHASE 1/2 TRIAL

SEQUOIA (Study 304) assessed the efficacy and safety of BRUKINSA in 589 adult patients with treatment-naïve CLL/SLL. SEQUOIA was a global Phase 3, randomized, open-label, multicenter study.¹

ALPINE (Study 305) assessed the efficacy and safety of BRUKINSA in 652 adult patients with relapsed/refractory CLL/SLL who had received ≥1 prior systemic therapy. ALPINE was a global Phase 3, randomized, open-label, multicenter trial.^1,3

AU-003 assessed the long-term safety and efficacy of BRUKINSA in 123 adult patients with treatment-naïve or relapsed/refractory CLL/SLL. AU-003 was a global supportive Phase 1/2, open-label, multicenter, single-arm trial.⁵

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; ORR=overall response rate; PFS=progression-free survival; SLL=small lymphocytic lymphoma.

VIEW EFFICACY DATA

CONSISTENTLY LOW RATES OF AFIB/FLUTTER AND DISCONTINUATION ACROSS TRIALS

CONSISTENCY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENCY IN AN ADDITIONAL TRIAL (PHASE 1/2)

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

VIEW 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.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed March 7, 2023. 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.; 2023. 2. 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. 3. 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. 4. Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers: Guidance for Industry. US Department of Health and Human Services, Food and Drug Administration; 2018. Accessed December 20, 2022. https://www.fda.gov/media/102575/download 5. Cull G, Burger JA, Opat S, et al. Zanubrutinib for treatment-naïve and relapsed/refractory chronic lymphocytic leukaemia: long-term follow-up of the phase I/II AU-003 study. Br J Haematol. 2022;196(5):1209-1218. 6. Tam C, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-859. 7. National Comprehensive Cancer Network. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2023.

Want to learn about a different indication?

WM MCL MZL

BRUKINSA for CLL The BRUKINSA Difference

Study Design Efficacy Safety