SAN CARLOS, Calif. - Thursday, 20. November 2025
BRUKINSA now demonstrates best-in-class sustained efficacy and long-term benefit with a favorable safety profile over more than six years of follow-up data in treatment-naïve and R/R CLL
First results from Phase 1/2 sonrotoclax monotherapy study will demonstrate notable speed and depth of clinical responses in patients with R/R MCL, a rare, aggressive cancer
New efficacy and safety data will highlight the benefits of potential first-in-class BTK degrader BGB-16673 in patients across multiple hematological malignancies
(BUSINESS WIRE) -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, advances its vision to become the world’s leading oncology company with extensive new data from its differentiated hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida, December 6-9. Nearly 50 abstracts have been accepted, including six oral presentations, featuring the company’s three transformative approved and investigational hematology assets – BTK inhibitor BRUKINSA® (zanubrutinib), BCL2 inhibitor sonrotoclax, and BTK degrader BGB-16673.
Key presentations include:
SEQUOIA: BRUKINSA demonstrated sustained overall survival (84%; 88% after COVID adjustment) and landmark progression-free survival (PFS) superiority vs bendamustine + rituximab with an estimated 74% PFS at 6 years in treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (Poster Presentation: 2129)
ALPINE: Post-hoc analysis from Phase 3 study of BRUKINSA versus ibrutinib in patients with relapsed/refractory (R/R) CLL/SLL, using longitudinal patient-reported outcomes (PRO) (Oral Presentation: 711)
BGB-11417-201: Phase 1/2 study of sonrotoclax in patients with R/R mantle cell lymphoma (MCL) previously treated with a BTK inhibitor (Oral Presentation: 663)
BGB-11417-101: Updated safety and efficacy results, including undetectable minimal residual disease (uMRD) data, from ongoing Phase 1/1b study of sonrotoclax plus BRUKINSA in treatment-naïve CLL/SLL (Poster Presentation: 3891)
CaDAnCe-101: Updated efficacy and safety results of BGB-16673 in patients with R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) (Oral Presentation: 85; Poster Presentation: 3583)
“Our data at ASH 2025 raises the bar for patient and physician expectations of what’s possible. Our long-term data drives confidence in duration of response in CLL treatment decisions,” said Lai Wang, Ph.D., Global Head of R&D at BeOne. “Six-year SEQUOIA and long-term extension data from patients originally enrolled in ALPINE cement BRUKINSA’s role as the backbone of CLL therapy, and our three innovative B-cell treatment modalities of BTK inhibition, BCL2 inhibition, and BTK degradation have the potential to advance options that evolve with patient needs across all stages of disease.”
Additional highlights include:
Never-before-presented clinical data from BeOne’s emerging pipeline will also be shared at the meeting, including in new combinations and disease areas.
BGB-11417-101: Results from Phase 1/1b study:
MRD-guided therapy of sonrotoclax plus obinutuzumab in patients with treatment-naïve CLL/SLL (Oral Presentation: 793)
Initial results of treatment with sonrotoclax plus BRUKINSA plus obinutuzumab in patients with treatment-naïve CLL/SLL (Poster Presentation: 3890)
BGB-11417-202: Phase 2 study of sonrotoclax monotherapy in patients with R/R CLL/SLL (Poster Presentation: 5666)
BGB-11417-105: Initial results from Phase 1b/2 study of sonrotoclax plus carfilzomib and dexamethasone in patients with t(11;14)-positive R/R multiple myeloma (Oral Presentation: 102)
CaDAnCe-101 Preliminary results from the ongoing Phase 1 study of BGB-16673 in patients with R/R Richter’s transformation (Poster Presentation: 3895)
Ongoing clinical data from BRUKINSA continue to demonstrate clinically meaningful benefit for patients with CLL/SLL.
SEQUOIA Arm D: Single-arm study of BRUKINSA plus venetoclax in patients with first-line CLL/SLL, with del(17p) and/or TP53 mutation or without both (Poster Presentation: 5669)
ALPINE thru LTE1: Up to 6 years of follow-up of patients with R/R CLL/SLL who were originally randomized to receive BRUKINSA as part of the ALPINE study and continued BRUKINSA treatment in a long-term extension study (LTE-1) (Poster Presentation: 2123)
Presentations also include data leveraging real-world evidence and validated modeling approaches to refine understanding of real-world experience and outcomes achieved with covalent BTK inhibitors.
Outcomes research:
A model analysis of number needed to treat (NNT) estimates that treating patients with BRUKINSA instead of ibrutinib for CLL could potentially prevent approximately 255 cardiac deaths in the second-line or later (2L+) setting and 266 in the first-line (1L) setting over a 10-year period. (Abstract Number: 13636)
Model evaluating BRUKINSA vs other covalent BTK inhibitors in R/R CLL and the number of patients needed to treat to avoid progression or death (Poster Presentation: 4553)
Observational study examining patient-reported outcomes in U.S. patients with CLL/SLL and treated with BRUKINSA or acalabrutinib in the community oncology setting (Poster Presentation: 2768)
“In CLL, selecting the right therapy for the right patient at the right time is essential, and continuous treatment with BTK inhibitors like BRUKINSA has become central to achieving enduring disease control,” said Dany Habr, M.D., Senior Vice President and Head of Medical Affairs, North America & International Markets at BeOne. “Emerging data from real-world settings suggest that BRUKINSA may offer a more manageable side effect profile, including for symptoms such as fatigue, pain, headache – further supporting its role as the BTKi of choice.”
BeOne Presentations at ASH 2025 (organized chronologically by asset)
BRUKINSA: The backbone of the hematology franchise
Abstract Title
Presentation Details
Lead Author
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
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
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
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
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
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
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
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
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
Abstract Title
Presentation Details
Lead Author
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
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
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
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
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
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
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
Abstract Title
Presentation Details
Lead Author
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
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
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
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
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
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
Abstract Title
Presentation Details
Lead Author
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
Abstract Title
Presentation Details
Lead Author
Matching-Adjusted Indirect Comparison
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
A matching-adjusted indirect comparison of zanubrutinib vs venetoclax + ibrutinib in treatment-naive CLL
Abstract Number: 7756
Talha Munir
Health Economic and Outcomes Research
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
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
Estimated cardiac deaths associated with treating CLL with ibrutinib versus zanubrutinib in the United States
Abstract Number: 13636
Jennifer R. Brown
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
Number of cardiac deaths associated with ibrutinib versus zanubrutinib for the treatment of CLL: A European risk-based estimation
Abstract Number: 14028
Talha Munir
Real-World Evidence
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
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
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
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
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
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
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
Real-world treatment utilization, sequencing, and outcomes in mantle cell lymphoma: Emerging treatment patterns in the United States
Abstract Number: 13378
Alvaro Alencar
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
Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib
Abstract Number: 7341
Ryan Jacobs
Real-world CLL-specific biomarker testing patterns and frontline treatment patterns in patients with CLL/small lymphocytic lymphoma
Abstract Number: 7773
Timothy Reynolds
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
Patient Preference
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
Evaluating patient preferences for CLL in Korea: A discrete choice experiment
Abstract Number: 4019
Byung Woo Yoon
Systemic Literature Review
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: congress.beonemedicines.com.
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 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 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 Newsroom.
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