\n\u201cAt ASH 2025, we will present new data from across our CLL franchise, highlighting both the strength of BRUKINSA and the potential of BGB-16673,\u201d said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne. \u201cLong-term data are the gold standard in CLL, and BRUKINSA continues to deliver the high levels of durable progression-free and overall survival that patients and physicians should demand from a BTK inhibitor. BGB-16673, the most advanced BTK degrader in the clinic with over 800 patients dosed to date, potentially represents the next wave of foundational innovation in oncology.\u201d\n<\/p>\n
BRUKINSA continues to demonstrate unprecedented long-term efficacy with a favorable safety profile over more than six years of follow-up in treatment-na\u00efve CLL\/SLL.<\/i><\/b><\/p>\n
\nIn SEQUOIA (NCT03336333<\/a>), a randomized, multicenter, global Phase 3 trial, BRUKINSA maintained progression-free survival (PFS) superiority versus bendamustine plus rituximab (BR) with an estimated 74% PFS at six years in treatment-na\u00efve CLL or small lymphocytic lymphoma (SLL) compared with 32% PFS for BR. Highlights include:\n<\/p>\n \n\u201cSEQUOIA\u2019s longer follow-up strengthens the evidence for continuous zanubrutinib use,\u201d said Constantine Tam, M.B.B.S., M.D., Head of Lymphoma Service at Alfred Health and Professor of Haematology at Monash University. \u201cPatients continued to show durable disease control and consistent safety across study arms, meaningfully raising the bar for CLL patients, including those with harder-to-treat CLL.\u201d\n<\/p>\n New patient-reported outcomes data in R\/R CLL suggest BRUKINSA may offer a more manageable side effect profile. Up to six-years of follow-up data support BRUKINSA\u2019s foundational role in CLL\/SLL as the only BTK inhibitor with enduring PFS and long-term benefit over another BTK inhibitor.<\/i><\/b><\/p>\n \nALPINE (NCT03734016<\/a>) is a global, randomized, open-label, multicenter, Phase 3 study of BRUKINSA versus ibrutinib in patients with R\/R CLL\/SLL who received \u22651 prior systemic therapy. Highlights include:\n<\/p>\n BGB-16673 (BTK degrader) clinical data demonstrates rapid, robust and deepening responses in patients with heavily pretreated R\/R CLL\/SLL, including those with prior BTKi treatment and mutations that confer resistance to BTK inhibitors. (<\/i><\/b>Oral Presentation: 85<\/i><\/b><\/a>)<\/i><\/b><\/p>\n \nUpdated results from CaDAnCe-101 (NCT05006716<\/a>), an ongoing open-label, Phase 1\/2 study evaluating BGB-16673 monotherapy in patients with B-cell malignancies, showed responses across R\/R CLL\/SLL patient types, including those who had previously been treated with BTK inhibitors, BCL2 inhibitors, noncovalent BTK inhibitors, and those with BTK inhibitor resistance mutations. <\/i>Highlights include:\n<\/p>\n \nFor more information about our presence at the 2025 ASH Annual Meeting and Exposition, please visit our meeting hub: congress.beonemedicines.com<\/a>.\n<\/p>\n About Chronic Lymphocytic Leukemia<\/b><\/p>\n \nChronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.1,2<\/sup> CLL is the most common type of leukemia in adults, accounting for about one-third of new cases.2,3<\/sup><\/p>\n About BGB-16673<\/b><\/p>\n \nBGB-16673 is a potential first-in-class Bruton\u2019s tyrosine kinase (BTK) protein degrader and is the most advanced protein degrader in the clinic, with nearly 800 patients dosed to date in an extensive global clinical development program. 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\u2019s chimeric degradation activation compound (CDAC) platform, BGB-16673 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.\n<\/p>\n \nThe U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 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 BGB-16673 PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom\u2019s macroglobulinemia (WM) previously treated with a BTK inhibitor.\n<\/p>\n About BRUKINSA\u00ae<\/sup> (zanubrutinib)<\/b><\/p>\n \nBRUKINSA is an orally available, small molecule inhibitor of Bruton\u2019s 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.\n<\/p>\n \nBRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study.\n<\/p>\n \nThe global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 247,000 patients have been treated globally.\n<\/p>\n Select Important Safety Information<\/b><\/p>\n \nSerious 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).\n<\/p>\n \nIn the pooled safety population (N=1729), the most common adverse reactions (\u226530%), 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%).\n<\/p>\n \nPlease see full U.S. Prescribing Information<\/a> including U.S. Patient Information<\/a>.\n<\/p>\n The information provided in this press release is intended for a global audience. Product indications vary by region.<\/b><\/p>\n About BeOne<\/b><\/p>\n \nBeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to 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. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.\n<\/p>\n \nTo learn more about BeOne, please visit www.beonemedicines.com<\/a> and follow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a> and Instagram<\/a>.\n<\/p>\n Forward-Looking Statement<\/b><\/p>\n \nThis 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 BGB-16673; and BeOne\u2019s plans, commitments, aspirations and goals under the caption \u201cAbout BeOne.\u201d Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne\u2019s 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\u2019s 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\u2019s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne\u2019s 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 \u201cRisk Factors\u201d in BeOne\u2019s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne\u2019s 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.\n<\/p>\n \nTo access BeOne media resources, please visit ourNewsroom<\/b><\/a>.\n<\/p>\n 1<\/sup> National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)\u2013Patient Version. Accessed November 2024. https:\/\/www.cancer.gov\/types\/leukemia\/hp\/cll-treatment-pdq<\/a>. View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20251208674374\/en\/<\/a><\/span><\/p>\n Investor Contact Media Contact KEYWORDS:<\/b> California Florida United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n\n
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2<\/sup> American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2024. https:\/\/www.cancer.org\/cancer\/types\/chronic-lymphocytic-leukemia\/about\/what-is-cll.html<\/a>.
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3<\/sup> American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed November 2024. https:\/\/www.cancer.org\/cancer\/types\/chronic-lymphocytic-leukemia\/about\/key-statistics.html<\/a>.\n<\/p>\n<\/p>\n
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Liza Heapes
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+1 857-302-5663
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ir@beonemed.com<\/a><\/p>\n
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Kyle Blankenship
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+1 667-351-5176
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media@beonemed.com<\/a><\/p>\n
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