BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026

(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA^® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 patients, underscoring consistent effectiveness and safety in clinical practice. Additionally, BEQALZI^™ (sonrotoclax), which was recently approved by the U.S. Food and Drug Administration, and its development in combination with BRUKINSA (ZS) highlight the potential for next-generation, time-limited treatment approaches in CLL.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
“CLL is a disease patients live with for years, and the real measure of a therapy is how it performs over the long arc of treatment. Our data at ASCO show that BRUKINSA continues to deliver sustained disease control, which can give physicians and patients confidence to stay the course. Additionally, robust, real-world analyses reinforce its role as a best-in-class BTK inhibitor, with data favoring BRUKINSA over other BTK inhibitors across several efficacy and safety endpoints. With BRUKINSA as the foundation, we are building a broad, differentiated hematology franchise designed to push the field further, including our ZS combination, which achieved deep responses and unprecedented rates of uMRD, and emerging approaches like our BTK degrader, tacabrutideg. Together, these foundational therapies reflect our commitment to redefining what patients should expect from therapy both today and in the future.”

78-month SEQUOIA data highlight the long-term impact of first-line treatment choice in CLL (Poster Presentation: 544; June 1, 2026, 9:00 AM-12:00 PM CDT)
SEQUOIA now provides the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, enabling a deeper understanding of how treatment outcomes evolve over time. After a median follow-up of 84.01 months (range, 0.0-101.5), BRUKINSA continued to show benefit over bendamustine-rituximab (BR) in patients with treatment-naive CLL/SLL, with progression-free survival (PFS) outcomes that are unprecedented among BTK inhibitors. Key highlights include:

• 78-month PFS: 71.8% (95% CI, 65.3-77.3) for BRUKINSA vs. 31.0% (95% CI, 24.3-37.9) for BR
• 78-month COVID-adjusted PFS: 74.6% (95% CI, 68.1-79.9) for BRUKINSA vs. 31.4% (95% CI, 24.7-38.4) for BR
  • PFS for patients with unmutated IGHV: 70.4% (95% CI, 61.0-77.9) for BRUKINSA vs. 17.4% (95% CI, 9.6-27.1) for BR
  • PFS for patients with mutated IGHV: 81.8% (95% CI: 72.2-88.4) for BRUKINSA and 45.1% (95% CI: 34.4-55.2) for BR
• 78-month PFS2: 81.3% (95% CI, 75.6-85.8) for BRUKINSA vs. 74.4% (95% CI, 67.8-79.8) for BR
• 78-month COVID-adjusted PFS2: 84.7% (95% CI, 79.2-88.8) for BRUKINSA and 76.4% (95% CI, 69.9-81.7) 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 (HR, 0.24; 95% CI, 0.16-0.35; P<.0001)
• Safety: consistent with the results of prior BRUKINSA studies with no new safety signals.

PFS2 captures outcomes beyond first disease progression, measuring time to disease progression on subsequent therapy or death. In CLL, this endpoint provides important insight into how first-line treatment impacts long-term disease control across multiple lines of therapy.

Constantine Tam, M.B.B.S., M.D., Head of Lymphoma Service at Alfred Health and Professor of Haematology at Monash University, said:
“In an indolent disease like CLL, many patients value maintaining disease control over the course of their life, not just in the first year or two of treatment. The continued long-term follow-up from SEQUOIA shows that zanubrutinib can deliver sustained disease control. This is the kind of evidence that allows clinicians and patients to make first-line decisions with real confidence about what lies ahead.”

Real-world efficacy and safety data consistently underscore foundational BRUKINSA as the best-in-class BTKi for TN CLL (Poster Presentations: 545, 543 and 540; June 1, 2026, 9:00 AM-12:00 PM CDT)
In addition to the update from SEQUOIA, BeOne will present data from new analyses of large and robust datasets, 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. (Poster Presentation: 545)
• In a separate real-world analysis of Komodo database claims from 16,788 patients with treatment-naïve CLL, BRUKINSA had a longer TTNT (unadjusted HR, 0.88; 95% CI, 0.79-0.97; P=.009) and overall survival (OS; HR, 0.72; 95% CI, 0.62-0.82; P<.001). (Poster Presentation: 543)
• A retrospective analysis of 233,362 newly diagnosed CLL patients who initiated treatment with a BTK inhibitor, the atrial fibrillation rate within 1 year was lowest for BRUKINSA at 11% and 13% for acalabrutinib and 16% for ibrutinib (overall P<.0001). (Poster Presentation: 540)

Deep, rapid responses with BRUKINSA plus sonrotoclax (ZS) point to the future of time-limited treatment in CLL, including high-risk disease (Poster Presentation: 541; June 1, 2026, 9:00 AM-12:00 PM CDT)
In the Phase 1/1b study in patients with treatment-naïve CLL/SLL (median follow-up of ~34 months), the all-oral combination of BRUKINSA and next-generation BCL2 inhibitor sonrotoclax (ZS) demonstrated unprecedented rates and kinetics of undetectable minimal residual disease (uMRD), including in patients with high-risk cytogenetics. Key highlights include:

• Overall response rate (ORR): 100%, with complete responses in 59.5% of patients
• Best uMRD4 rate 98.8%
  • No patient that achieved uMRD4 reverted to uMRD positivity.
• Best uMRD in patients with TP53 mutation/del(17p): 92.9% across 2 dose levels
• Median time from combination start to uMRD4: 4.5 months
• No disease progression events observed at the recommended Phase 2 dose of 320mg, including patients who electively discontinued therapy
• Safety: consistent with previously reported BRUKINSA and sonrotoclax combination studies.

These data will also be presented as encore presentations at the 2026 European Hematology Association (EHA) Congress (June 11–14, Stockholm) along with more than 30 other data sets from BeOne.

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.

About BEQALZI^™ (sonrotoclax)
BEQALZI^™ (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,500 patients have been enrolled across the broad sonrotoclax global development program.

BEQALZI is approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a BTK inhibitor. It is also approved in China for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor.

About Tacabrutideg (BGB-16673)
Tacabrutideg is a foundational and potential first-in-class and best-in-class orally available Bruton’s tyrosine kinase (BTK) degrader. With 1,200+ patients dosed to date in an extensive global clinical development program, tacabrutideg is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, tacabrutideg is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease.

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tacabrutideg for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted tacabrutideg PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

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.

Select Important Safety Information for BEQALZI^™ (sonrotoclax)
Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome.

In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%).

Please see full Prescribing 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 patient benefits of zanubrutinib, sonrotoclax and tacabrutideg; BeOne’s ability to redefine what patients should expect from therapy; 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.

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