Efficacy for BRUKINSA® (zanubrutinib) for CLL/SLL.

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

SUPERIOR EFFICACY vs BR IN FIRST LINE AND vs IBRUTINIB IN SECOND LINE

FIRST LINE

SUPERIOR PFS vs BR IN PATIENTS WITHOUT DEL(17p) AND CONSISTENT PFS IN PATIENTS WITH DEL(17p)^1,2

Cohort 2: The largest prospective study of 1L patients with del(17p)

In Cohort 1, median PFS was not yet reached in either arm at median follow-up of 26.2 months.²

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.²

IN PATIENTS WITHOUT DEL(17p):
PFS GENERALLY FAVORED BRUKINSA REGARDLESS OF MUTATION OR RISK STATUS*²

All subgroup analyses are exploratory and descriptive in nature.

*Assessed by IRC.

^†Hazard ratio and 95% CI were from stratified (for all patients) or unstratified analysis (for subgroup) Cox regression model with BR arm as the reference group.

HIGH ORR IN PATIENTS WITH AND WITHOUT DEL(17p)^1,2

Cohort 1: without del(17p)

secondary endpoint*

93% ORR

with BRUKINSA at ~2 years

(95% CI: 89.0, 96.0) vs 85%

with BR (95% CI: 80.0, 90.0)

Cohort 2: with del(17p)

secondary endpoint^†

88% ORR

with BRUKINSA

(95% CI: 81.0, 94.0)

*Prespecified analysis assessed by IRC; median follow-up of 26.2 months.²

^†Prespecified analysis assessed by IRC; median follow-up of 30.5 months.²

1L=first line; BR=bendamustine+rituximab; CI=confidence interval; CLL=chronic lymphocytic leukemia; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=independent review committee; ITT=intent to treat; ORR=overall response rate; PFS=progression-free survival.

READ THE SEQUOIA (1L) PUBLICATION

SECOND LINE

THE ONLY BTKi TO ACHIEVE SUPERIOR PFS vs IBRUTINIB³

Median PFS has not yet been reached with BRUKINSA vs 34 months with ibrutinib*

Data presented are consistent with label.⁴

Statistical analysis for PFS was conducted for noninferiority. When noninferiority was met, superiority was tested.³

*Assessed by both IRC and investigator with similar results.³

CONSISTENT PFS vs IBRUTINIB, REGARDLESS OF MUTATION OR RISK STATUS*³

All subgroup analyses are exploratory and descriptive in nature.

*Assessed by both IRC and investigator with similar results.

^†Hazard ratio and 95% CI were unstratified for subgroups.

THE ONLY BTKi TO ACHIEVE SUPERIOR ORR vs IBRUTINIB¹

With BRUKINSA, 92% of patients sustained a response vs 86% with ibrutinib at 1 year

Statistical analysis for ORR was conducted for noninferiority. When noninferiority was met, superiority was tested.³

*Assessed by both IRC and investigator with similar results.^1,3

CONSISTENT ORR vs IBRUTINIB, REGARDLESS OF MUTATION OR RISK STATUS³

All subgroup analyses are exploratory and descriptive in nature.

Assessed by both IRC and investigator with similar results. Median follow-up of 24.7 months.^1,3

2L=second line; BTKi=Bruton's tyrosine kinase inhibitor; CI=confidence interval; CR=complete response; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=independent review committee; nPR=nodular partial response; ORR=overall response rate; PFS=progression-free survival; PR=partial response.

READ THE ALPINE (2L) PUBLICATION

Dr Anthony Nguyen discusses efficacy data across mutations and risk status in CLL

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LONG-TERM DATA

STUDY 003:

A global supportive Phase 1/2, open-label, single-arm trial that included patients with treatment-naïve or relapsed/refractory CLL/SLL and evaluated ~4 years of safety and ~3 years of efficacy data.⁵

BRUKINSA PROVIDED CONSISTENT PFS ACROSS LINES OF THERAPY AT ~3 YEARS⁵

Exploratory long-term analysis; all data are descriptive in nature.

*Assessed by IRC.

BRUKINSA PROVIDED CONSISTENT ORR ACROSS LINES OF THERAPY AT ~3 YEARS⁵

86% of patients had an ongoing response at 3 years, regardless of line of therapy

Exploratory long-term analysis; all data are descriptive in nature.

Study 003 was a global supportive Phase 1/2 trial for 1L and 2L CLL.

*Assessed by IRC.

1L=first line; 2L=second line; CI=confidence interval; CLL=chronic lymphocytic leukemia; CR=complete response; ORR=overall response rate; PFS=progression-free survival; PR=partial response; SLL=small lymphocytic lymphoma.

READ THE STUDY 003 (1L/2L) PUBLICATION

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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.

Want to learn about a different indication?

WM MCL MZL

BRUKINSA for CLL The BRUKINSA Difference

Study Design Efficacy Safety