BRUKINSA patients can call the myBeOne Support^™ program to talk to a dedicated nurse: 1-833-234-4363

SUPERIOR EFFICACY ACROSS LINES OF THERAPY

Sustained efficacy at ~3.5-year and ~5-year milestone analyses

1L: SEQUOIA

SUPERIOR PFS vs BR WITH SUSTAINED EFFICACY AT THE LONG-TERM MILESTONE ANALYSES^1-458% relative risk reduction in disease progression or death with BRUKINSA vs BR at the superiority analysis (Cohort 1; primary endpoint; HR=0.42; 95% CI: 0.28, 0.63; p<0.0001; median follow-up: 26.2 months)*^†

71% relative risk reduction in disease progression or death with BRUKINSA vs BR at ~5 years^‡
Cohort 1: patients without del(17p)/TP53

KM curve showing superior PFS data vs BR for SEQUOIA

Consistent PFS in BRUKINSA-only arm at ~4 years^‡
Cohort 2: patients with del(17p) +/-TP53

KM curve showing PFS data for patients with del(17p) in the SEQUOIA BRUKINSA® (zanubrutinib)-only arm

*Median PFS was not reached in either arm at the initial analysis.^1,2

^†Prespecified analysis assessed by IRC.²

^‡Analyses are exploratory and descriptive in nature.

IN PATIENTS WITHOUT DEL(17p)/TP53:
PFS GENERALLY FAVORED BRUKINSA AT ~5 YEARS, REGARDLESS OF MUTATION OR RISK STATUS*^†3

PFS data from SEQUOIA for patients without del(17p)/TP53 taking BRUKINSA® (zanubrutinib)

*Assessed by investigator.³

^†Median follow-up at the long-term analysis: 61.2 months.³

^‡The hazard ratio and 95% CI were assessed using a stratified (for all patients) or unstratified (for subgroup) Cox regression model with the BR arm as the reference arm.³

^§Cytopenia: anemia (hemoglobin ≤110 g/L), thrombocytopenia (platelet count ≤100 x 10⁹/L), or neutropenia (absolute neutrophil count ≤1.5 x 10⁹/L).³

^¶On the basis of monosomy 13q mutation results.³

HIGH ORR IN PATIENTS WITHOUT DEL(17p)/TP53 AND WITH DEL(17p) IN THE INITIAL ANALYSIS^1,2

Cohort 1: without del(17p)/TP53

secondary endpoint*

93% ORR

with BRUKINSA (n=241) at ~2 years

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

with BR (n=238) (95% CI: 80.0, 90.0)

Cohort 2: with del(17p)

secondary endpoint^†

88% ORR

with BRUKINSA (n=110)

(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; HR=hazard ratio; IRC=independent review committee; LDi=longest diameter; ORR=overall response rate; PFS=progression-free survival; VAF=variant allele frequency.

READ THE SEQUOIA (1L) PUBLICATION READ THE SEQUOIA ~5-YEAR MILESTONE ANALYSIS

2L: ALPINE

SUPERIOR PFS vs IBRUTINIB WITH SUSTAINED EFFICACY AT ~3.5-YEAR MILESTONE ANALYSIS^1,5,635% relative risk reduction in disease progression or death with BRUKINSA vs ibrutinib in all-comers at the superiority analysis (secondary endpoint; HR=0.65; 95% CI: 0.49, 0.86; p=0.0024; median follow-up: 31 months)*

32% relative risk reduction in disease progression or death with BRUKINSA vs ibrutinib at ~3.5 years^†
all-comer population

KM curve showing PFS data for the all-comer population in ALPINE

49% relative risk reduction in disease progression or death vs ibrutinib^†
patients with del(17p) +/-TP53

KM curve showing PFS data for patients with del(17p)/TP53 in ALPINE

*Prespecified analysis assessed by both IRC and investigator with similar results. Median PFS has not yet been reached with BRUKINSA vs 34 months with ibrutinib.⁵

^†Analyses are exploratory and descriptive in nature.

CONSISTENT PFS vs IBRUTINIB AT INITIAL ANALYSIS, REGARDLESS OF MUTATION OR RISK STATUS*^†5

Consistent PFS across subgroups in ALPINE

All subgroup analyses are exploratory and descriptive in nature.

*Assessed by both IRC and investigator with similar results.⁵

^†Median follow-up at the initial analysis: 31 months.¹

^‡Hazard ratio and 95% CI were unstratified for subgroups.⁵

THE ONLY BTKi TO ACHIEVE SUPERIOR ORR vs IBRUTINIB¹Initial analysis
(25 months for ORR)

Median follow-up: 24.7 months⁷

With BRUKINSA, 92% of patients sustained a response vs 86% with ibrutinib at 1 year¹

Statistical analysis for ORR was conducted for noninferiority. When noninferiority was met, superiority was tested.⁵

*Assessed by both IRC and investigator with similar results.^1,5

BRUKINSA DEMONSTRATED MORE COMPLETE RESPONSES OVER TIME vs IBRUTINIB⁶

Bar chart showing complete responses over time (PR+PR-L+nPR and CR+CRi) for BRUKINSA (zanubrutinib) vs ibrutinib from ALPINE

Exploratory analyses.

CONSISTENT ORR vs IBRUTINIB AT INITIAL ANALYSIS, REGARDLESS OF MUTATION OR RISK STATUS⁵

Consistent ORR across subgroups in ALPINE

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.^1,5,7

2L=second line; BTKi=Bruton's tyrosine kinase inhibitor; CI=confidence interval; CR=complete response; CRi=complete response with absolute neutrophil count <1,000/µL; 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; PR–L=partial response with lymphocytosis.

READ THE ALPINE (2L) PUBLICATION READ THE ALPINE ~3.5-YEAR MILESTONE ANALYSIS

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

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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

Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

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.; 2025. 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. Shadman M, Munir T, Robak T, et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: median 5-year follow-up of SEQUOIA. J Clin Oncol. Published online December 8, 2024. doi:10.1200/JCO-24-02265 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, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388(4):319-332. 6. Brown JR, Eichhorst B, Lamanna N, et al. Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE. Blood. Published online September 24, 2024. doi:10.1182/blood.2024024667 7. Data on file. BeiGene USA, Inc.

Want to learn about a different indication?

WM MCL MZL FL

BRUKINSA for CLL The BRUKINSA Difference

Study Design (1L & 2L)Efficacy (1L & 2L)Safety (1L & 2L)Tolerability vs Other BTKis