SAN CARLOS, Calif. -
Nearly two-thirds of patients aged 80+ treated with BRUKINSA remained progression-free at six years, despite advanced age and high-risk features
New European patient research reveals safety, disease severity, and effectiveness are the top drivers for first-line CLL treatment decisions – not time on therapy
(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) aged 80 and older, showing sustained benefit with BRUKINSA after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial.1 These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden.
Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"While the median age of diagnosis for CLL is 70 and the average age of treatment initiation is 75, many pivotal trials still underrepresent the patients that physicians most often see in practice. These data show that the durable benefit of BRUKINSA extends to patients in their 80s, including those with high-risk features. Just as importantly, the consistently low rates of atrial fibrillation observed with BRUKINSA across clinical trials and real-world evidence reinforce its favorable tolerability profile in an older population, providing important confidence in first-line treatment decisions and supporting its role as the foundational BTK inhibitor in CLL.”
SEQUOIA subgroup analysis showed that age did not limit benefit in patients with CLL treated with BRUKINSA (Poster Presentations: PS1703; June 13, 6:45-7:45 PM CEST)
In this analysis of SEQUOIA, 38 patients aged 80 or older at study entry received BRUKINSA. The median age was 81 years (range, 80–87), and the population carried substantial high-risk burden: 36.8% had del(17p) and/or TP53 mutation, and 57.9% had unmutated IGHV. After a median follow-up of 78.8 months, BRUKINSA-treated patients continued to show durable benefit. Key highlights include:
Overall response rate (ORR): 100%, with a complete response rate of 18.4%
72-month progression-free survival (PFS): 63.8% (95% CI, 44.6–77.8)
72-month overall survival (OS): 75.9% (95% CI, 58.7–86.7)
36.8% of patients remain on BRUKINSA
Safety: Consistent with the established safety profile for BRUKINSA across long-term follow-up, with tolerability that supports long-term treatment in older patients.
Alessandra Tedeschi, M.D., Ph.D., consultant in hematology and Medical Director of the Department of Hematology at the Niguarda Cancer Center in Milan, Italy, said:
"Treating CLL in patients in their 80s involves many considerations, as they often have other underlying health conditions and there has been little long-term evidence in this population to guide us. What stands out with this analysis from SEQUOIA is the durability we saw in elderly patients treated with zanubrutinib, including in patients with high-risk features, as well as the manageable safety profile. Together, these results give physicians additional long-term data to draw on when treating this population."
Addressing the evidence gap in older patients with CLL
CLL is predominantly a disease of older adults. The median age at diagnosis is 70, with approximately 69% of new cases diagnosed in patients aged 65 or older and 36% diagnosed at age 75 or older.2 Despite this demographic reality, adults aged 80 and older have historically been underrepresented in pivotal CLL trials, creating uncertainty about the optimal management of the patients most clinicians actually treat.3
The implications go beyond age itself. Patients with CLL carry a substantial burden of comorbidities, particularly cardiovascular disease. A study of CLL patients found that 32% had prevalent cardiovascular disease, the majority of whom carried three or more distinct cardiovascular conditions.4 These risks intensify with age. For example, atrial fibrillation prevalence rises sharply across a person’s life span, reaching approximately 9% in adults aged 80 or older.5 In CLL, the risk of incident atrial fibrillation also increases with age, with the highest risk in patients aged 75 and older.6
This subgroup analysis helps address that gap, providing long-term data in the patients most often seen in clinical practice.
78-month SEQUOIA data reinforce BRUKINSA as the foundational BTK inhibitor in CLL (Poster Presentation: PF601)
The subgroup analysis will be presented alongside the 78-month SEQUOIA dataset, the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, showing a 78-month PFS of 71.8% for BRUKINSA versus 31.0% for bendamustine-rituximab. Additional highlights include:
78-month COVID-adjusted PFS: 74.6% for BRUKINSA vs. 31.4% for BR
PFS for patients with unmutated IGHV: 70.4% for BRUKINSA vs. 17.4% for BR
PFS for patients with mutated IGHV: 81.8% for BRUKINSA and 45.1% for BR
78-month PFS2: 81.3% for BRUKINSA vs. 74.4% for BR
78-month COVID-adjusted PFS2: 84.7% for BRUKINSA and 76.4% for BR
Of the BRUKINSA-treated patients who progressed (26/241), half received subsequent therapy with BCL2 inhibitor-based salvage therapy and 69.2% had not progressed after more than 3 years of follow-up.
Time to next treatment (TTNT) favored BRUKINSA over BR
Safety: consistent with the results of prior BRUKINSA studies with no new safety signals.
Real-world efficacy and safety data consistently underscore foundational BRUKINSA as the best-in-class BTKi for TN CLL (Poster Presentations: PB2901, PS2515, PF608)
In addition to updates from SEQUOIA, BeOne will present data from new analyses encompassing more than 250,000 patients, which demonstrate consistent and significant real-world benefits of using BRUKINSA over other BTK inhibitors. Key highlights include:
In a real-world analysis of 10,523 Medicare patients, who were diagnosed with CLL/SLL and received frontline treatment with a BTK inhibitor, patients treated with BRUKINSA had a statistically significantly lower risk of death, advancing to next line, or discontinuing treatment, than those on ibrutinib or acalabrutinib. Similar results were observed across age subgroups.
In a separate real-world analysis of Komodo database claims from 16,788 patients with treatment-naïve CLL, BRUKINSA had a longer TTNT and overall survival (OS).
A retrospective analysis of 233,362 newly diagnosed CLL patients who initiated treatment with a BTK inhibitor, in which the one-year atrial fibrillation rate was lowest for BRUKINSA at 11%, versus 13% for acalabrutinib and 16% for ibrutinib.
Patient preference analysis across five major European countries provides insights into factors that matter most to patients when making first-line CLL treatment decisions (PB2934)
A real-world analysis using AI-based semantic analysis examined 44,451 online messages from 2,699 patients with CLL across France, Germany, Italy, Spain, and the United Kingdom, posted between January 2020 and December 2025, to identify the factors frequently associated with first-line treatment decision-making from the patient perspective. Key findings include:
Treatment decisions were generally guided by hematologists; shared decision-making remains limited, with only 7% of patients in the United Kingdom and 11% in Germany explicitly reporting involvement in their treatment decision.
Safety (22-42% of captured conversations), clinical profile/disease severity (9–25%), and effectiveness (11-15%) were consistently the most frequently cited factors of treatment choice by the patients across all five countries.
Patients defined effectiveness as observable disease control, including remission, speed of response, and durability enabling a return to normal daily life.
Treatment duration, or how long patients remain on treatment, was among the least frequently mentioned factors influencing treatment choice, mentioned in fewer than 5% of conversations in every country.
These findings reinforce the importance of treatment conversations aligned with what patients report valuing the most — efficacy, safety, and shared decision-making — when navigating first-line CLL care.
About BRUKINSA® (zanubrutinib)
BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.
The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.
Select Important Safety Information for BRUKINSA
Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).
In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).
Please see full U.S. Prescribing Information including U.S. Patient Information.
The information provided in this press release is intended for a global audience. Product indications vary by region.
About BeOne
BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of BRUKINSA; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.
To access BeOne media resources, please visit our Newsroom.
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1 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.
2 National Cancer Institute. SEER Cancer Stat Facts: Chronic Lymphocytic Leukemia. National Cancer Institute, Bethesda, MD. May 28, 2026. https://seer.cancer.gov/statfacts/html/clyl.html.
3 Tsang M, Hampel PJ, Rabe KG, et al. Comparison of Frontline Therapies in Older Adults Age ≥ 80 Years With Chronic Lymphocytic Leukemia (CLL): A Mayo Clinic and Danish Nation-Wide Study. Am J Hematol. 2025;100(9):1678-1681. doi:10.1002/ajh.27747.
4 Mattsson M, Sandin F, Kättström M, et al. High prevalence and incidence of cardiovascular disease in chronic lymphocytic leukaemia: a nationwide population-based study. Br J Haematol. 2020;191(2):e51-e55. doi:10.1111/bjh.16859.
5 Martin SS, Aday AW, Allen NB, et al; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2025;151(8):e41-e660. doi:10.1161/CIR.0000000000001303.
6 Chen YC, Miranda P, Barqawi YK, et al. Cardiovascular safety outcomes of chronic lymphocytic leukemia treatments: a systematic and targeted literature review. Crit Rev Oncol Hematol. 2025.
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