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Beone Medicines Showcases Leadership In B-Cell Malignancies At ASH 2025
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Abstract Title |
Presentation Details |
Lead Author |
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Final analysis of the randomized Phase 2 ROSEWOOD study of zanubrutinib + obinutuzumab vs obinutuzumab monotherapy in patients with R/R follicular lymphoma |
Oral Presentation: 227 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: FL and WM Session Date/Time: December 6, 2025, 2:00-3:30 PM EST |
Pier Luigi Zinzani |
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Sustained efficacy of zanubrutinib vs bendamustine + rituximab in treatment- naïve CLL/SLL with continued favorable survival in non-randomized patients with del(17p): 6-year follow-up in the Phase 3 SEQUOIA study |
Poster Presentation: 2129 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Constantine S. Tam |
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Long-term results of patients receiving zanubrutinib in the Phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with R/R CLL/SLL: Up to 6 years of follow-up with the long-term extension |
Poster Presentation: 2123 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Constantine S. Tam |
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Symptom-based progression-free survival as a clinically relevant and patient-centric endpoint in CLL/SLL: Results from the ALPINE trial |
Oral Presentation: 711 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Quality of Life and Supportive Care in Lymphoid Malignancies Session Date/Time: December 7, 2025, 4:30-6:00 PM EST |
Jennifer R. Brown |
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Progression-free survival in patients with low health-related quality of life treated with zanubrutinib versus ibrutinib monotherapy: Post-hoc analysis of the ALPINE trial |
Poster Presentation: 6275 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Quality of Life and Supportive Care in Lymphoid Malignancies Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Loic Ysebaert |
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Zanubrutinib + venetoclax for treatment-naïve CLL/SLL, including patients with del(17p) and/or TP53 mutation and unmutated immunoglobulin heavy-chain variable status: 3-year results from SEQUOIA arm D |
Poster Presentation: 5669 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Mazyar Shadman |
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Evaluation of factors from established prognostic models in patients with CLL treated with zanubrutinib: A post-hoc analysis of two Phase 3 studies (SEQUOIA and ALPINE) |
Poster Presentation: 5681 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Inhye Ahn |
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Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies: A long-term follow-up |
Poster Presentation: 5663 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Mazyar Shadman |
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Single-arm, open-label, multicenter study of the BTKi zanubrutinib in patients with CD79B-mutated R/R diffuse large B-cell lymphoma |
Poster Presentation: 3684 Session Title: Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Li Wang |
Sonrotoclax: Potential best-in-class next-generation BCL2 inhibitor
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Presentation Details |
Lead Author |
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Initial Phase 1b/2 study results with sonrotoclax in combination with carfilzomib and dexamethasone in patients with t(11;14)-positive R/R multiple myeloma |
Oral Presentation: 102 Session Title: Multiple Myeloma: Pharmacologic Therapies: Advancing the Standard: Improving Myeloma Treatment through Diagnosis, Maintenance and Relapse Session Date/Time: December 6, 2025, 10:45-11:00 AM EST |
Hang Quach |
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A Phase 3, randomized, open-label, multicenter study of sonrotoclax plus anti-CD20 antibody therapies vs venetoclax plus rituximab in patients with R/R CLL/SLL (CLL-RR1/CELESTIAL-RRCLL) |
Trial-in-progress Poster Presentation: 2137 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Othman Al-Sawaf |
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Sonrotoclax monotherapy in patients with relapsed/refractory mantle cell lymphoma previously treated with BTKi: Early results from a Phase 1/2 study |
Oral Presentation: 663 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological - Novel Treatments for and Insights into Mantle Cell Lymphoma Session Date/Time: December 7, 2025, 4:30-6:00 PM EST |
Michael Wang |
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Frontline treatment of sonrotoclax and zanubrutinib for CLL/SLL demonstrates high undetectable minimal residual disease rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing Phase 1/1b study |
Poster Presentation: 3891 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Constantine S. Tam |
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Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naïve CLL/SLL: Initial results from an ongoing Phase 1/1b study, BGB-11417-101 |
Poster Presentation: 3890 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Jacob D. Soumerai |
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MRD-guided therapy of sonrotoclax + obinutuzumab in patients with treatment-naive CLL: Initial results from an ongoing Phase 1/1b study, BGB-11417-101 |
Oral Presentation: 793 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: MRD Guided Therapy and Emergence of Resistance Session Date/Time: December 8, 2025, 10:30 AM-12:00 PM EST |
Marc S. Hoffmann |
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Primary analysis of a multicenter, open-label, Phase 2 study of sonrotoclax monotherapy in patients with R/R CLL/SLL |
Poster Presentation: 5666 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Shuhua Yi |
BGB-16673: Potential first-in-class BTK protein degrader
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Abstract Title |
Presentation Details |
Lead Author |
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Updated efficacy and safety results of the BTK degrader BGB-16673 in patients with R/R CLL/SLL from the ongoing Phase 1 CaDAnCe-101 study |
Oral Presentation: 85 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Treatment of CLL in Relapse and in Richter Transformation Session Date/Time: December 6, 2025, 9:30-11:00 AM EST |
Inhye E. Ahn |
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CaDAnCe-104, an ongoing, open-label, Phase 1b/2 master protocol study of BTK degrader BGB-16673 in combination with other agents in patients with R/R B-cell malignancies |
Trial-in-Progress Poster Presentation: 1839 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Chan Y. Cheah |
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Updated efficacy and safety results of the BTK degrader BGB-16673 in patients with R/R indolent non-Hodgkin lymphoma from the ongoing Phase 1 CaDAnCe-101 study |
Poster Presentation: 3584 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Romain Guièze |
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Preliminary efficacy and safety of the BTK BGB-16673 in patients with R/R Richter transformation: Results from the ongoing Phase 1 CaDAnCe-101 study |
Poster Presentation: 3895 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Meghan C. Thompson |
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Updated efficacy and safety results of the BTK BGB-16673 in patients with R/R Waldenström macroglobulinemia from the ongoing Phase 1 CaDAnCe-101 study |
Poster Presentation: 3583 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Constantine S. Tam |
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CaDAnCe-304, a Phase 3, open-label, randomized study to evaluate the safety and efficacy of BTK degrader BGB-16673 compared with pirtobrutinib in patients with R/R CLL/SLL |
Trial-in-progress Poster Presentation: 5691 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Meghan C. Thompson |
Other hematology assets: BGB-21447, next-generation BCL2 inhibitor
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Abstract Title |
Presentation Details |
Lead Author |
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Preliminary results from a Phase 1/1b first-in-human study of BGB-21447, a next-generation BCL2 inhibitor, in patients with B-cell non-Hodgkin lymphoma |
Poster Presentation: 1910 Session Title: Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Fei Li |
Integrative evidence generation and health economics related to BRUKINSA
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Abstract Title |
Presentation Details |
Lead Author |
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Matching-Adjusted Indirect Comparison | ||
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Indirect comparison of efficacy of zanubrutinib vs ibrutinib for the treatment of R/R MCL |
Poster Presentation: 5365 Session Title: Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Toby A. Eyre |
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A matching-adjusted indirect comparison of zanubrutinib vs venetoclax + ibrutinib in treatment-naive CLL |
Abstract Number: 7756 |
Talha Munir |
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Health Economic and Outcomes Research | ||
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Outcomes during BTKi treatment for CLL: Insights from remote therapeutic monitoring |
Poster Presentation: 2768 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Gurjyot Doshi |
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Number needed to treat to avoid progression or death: Zanubrutinib vs other covalent BTKis in R/R CLL |
Poster Presentation: 4553 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Mazyar Shadman |
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Estimated cardiac deaths associated with treating CLL with ibrutinib versus zanubrutinib in the United States |
Abstract Number: 13636 |
Jennifer R. Brown |
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Number of patients needed to treat to prevent one atrial fibrillation event with zanubrutinib versus ibrutinib and acalabrutinib in B-cell malignancies |
Abstract Number: 14445 |
Talha Munir |
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Number of cardiac deaths associated with ibrutinib versus zanubrutinib for the treatment of CLL: A European risk-based estimation |
Abstract Number: 14028 |
Talha Munir |
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Real-World Evidence | ||
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Mediators of racial and ethnic inequities in access to front-line therapies for CLL in the United States: A real-world evidence study |
Poster Presentation: 2720 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Jacqueline C. Barrientos |
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Real-world treatment patterns and biomarker utilization among patients aged ≥65 years with CLL/SLL from 2020 to 2024 |
Poster Presentation: 2723 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Paul Hampel |
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Chemo ± immunotherapy remains utilized for CLL in the real-world practice: Unmet needs, treatment patterns, and age disparities in the United States |
Poster Presentation: 2762 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I Session Date/Time: December 6, 2025, 5:30-7:30 PM EST |
Javier Pinilla-Ibarz |
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Impact of testing for genetic markers on treatment selection and clinical outcomes among patients with CLL |
Poster Presentation: 3894 Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Brian Koffman |
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Treatment patterns and outcomes among patients treated with second-generation BTK inhibitors in CLL |
Poster Presentation: 4528 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Aryan Ayat |
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Changes in real-world treatment patterns over time by patient characteristics and time burden of treatment in CLL/SLL |
Poster Presentation: 6283 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Mengyang Di |
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Real-world treatment patterns and patient characteristics of venetoclax combination time-limited therapy for CLL |
Poster Presentation: 6317 Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III Session Date/Time: December 8, 2025, 6:00-8:00 PM EST |
Jing-Zhou Hou |
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Real-world treatment utilization, sequencing, and outcomes in mantle cell lymphoma: Emerging treatment patterns in the United States |
Abstract Number: 13378 |
Alvaro Alencar |
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Real-world zanubrutinib treatment patterns in CLL/SLL among a curated sample of US community oncology patients with prior acalabrutinib therapy |
Abstract Number: 8798 |
Jing-Zhou Hou |
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Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib |
Abstract Number: 7341 |
Ryan Jacobs |
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Real-world CLL-specific biomarker testing patterns and frontline treatment patterns in patients with CLL/small lymphocytic lymphoma |
Abstract Number: 7773 |
Timothy Reynolds |
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Real-world CLL/SLL treatment patterns at Florida Cancer Specialists & Research Institute among patients receiving zanubrutinib immediately following prior BTKi therapy |
Abstract Number: 13894 |
Amanda Warner |
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Patient Preference | ||
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Patient preferences and factors affecting patient treatment decisions for CLL in Japan |
Poster Presentation: 4406 Session Title: Health Services and Quality Improvement: Lymphoid Malignancies: Poster II Session Date/Time: December 7, 2025, 6:00-8:00 PM EST |
Sikander Ailawadhi |
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Evaluating patient preferences for CLL in Korea: A discrete choice experiment |
Abstract Number: 4019 |
Byung Woo Yoon |
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Systemic Literature Review | ||
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Patients with high-risk features in mantle cell lymphoma: A systematic literature review of clinical trials and real-world studies |
Abstract Number: 14130 |
Christine E. Ryan |
For additional information about our presence at the 2025 ASH Annual Meeting and Exposition, please visit our meeting hub: href="" rel="nofollow" beonemedicine.
About Sonrotoclax (BGB-11417)
Sonrotoclax is a next-generation and potentially best-in-class investigational B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Studies in the lab and during 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 and is in development as a monotherapy and in combination with other therapeutics, including BRUKINSA. Notably, in early clinical trials, sonrotoclax plus BRUKINSA has demonstrated rapid and unprecedented undetectable minimal residual disease (uMRD) rates in treatment-naïve patients with CLL. To date, more than 2,200 patients have been enrolled across the broad global development program.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for sonrotoclax for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). In addition, the FDA has granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia, as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.
About BGB-16673
BGB-16673 is a potential first-in-class Bruton's 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's 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.
The 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's macroglobulinemia (WM) previously treated with a BTK inhibitor.
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.
BRUKINSA 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.
The 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.
Select Important Safety Information
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 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.
To learn more about BeOne, please visit 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 BeOne's product and product candidates; bringing innovative and transformative medicines to patients; and BeOne's plans, commitments, aspirations and goals under the caption“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; BeOne's 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 NewsroomView source version on businesswire:
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