November 20, 2025 — Leads & Copy — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235) has released new data from its oncology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held in Orlando, Florida from December 6-9.
The company presented nearly 50 abstracts, including six oral presentations, showcasing its hematology assets, which include the BTK inhibitor BRUKINSA® (zanubrutinib), the BCL2 inhibitor sonrotoclax, and the BTK degrader BGB-16673.
Key presentations included data from the SEQUOIA trial, demonstrating sustained overall survival (84%; 88% after COVID adjustment) and progression-free survival (PFS) superiority with BRUKINSA® versus bendamustine + rituximab in treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The estimated PFS was 74% at 6 years.
A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA® versus ibrutinib in patients with relapsed/refractory (R/R) CLL/SLL was presented, utilizing longitudinal patient-reported outcomes (PRO).
Data from the BGB-11417-201 Phase 1/2 study of sonrotoclax in patients with R/R mantle cell lymphoma (MCL) previously treated with a BTK inhibitor was also presented.
Updated safety and efficacy results, including undetectable minimal residual disease (uMRD) data, were shared from the ongoing Phase 1/1b study of sonrotoclax plus BRUKINSA® in treatment-naïve CLL/SLL (BGB-11417-101).
The company also presented updated efficacy and safety results of BGB-16673 in patients with R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) from the CaDAnCe-101 trial.
According to Lai Wang, Ph.D., Global Head of R&D at BeOne, the data presented at ASH 2025 raises expectations for patient and physician outcomes. The long-term data reinforces confidence in the duration of response in CLL treatment decisions.
Never-before-presented clinical data from BeOne’s emerging pipeline, including new combinations and disease areas, was shared at the meeting.
Results from the Phase 1/1b study of MRD-guided therapy of sonrotoclax plus obinutuzumab in patients with treatment-naïve CLL/SLL (BGB-11417-101) were presented, as well as initial results of treatment with sonrotoclax plus BRUKINSA® plus obinutuzumab in the same patient population.
Initial results from the Phase 1b/2 study of sonrotoclax plus carfilzomib and dexamethasone in patients with t(11;14)-positive R/R multiple myeloma (BGB-11417-105) were presented, along with preliminary results from the ongoing Phase 1 study of BGB-16673 in patients with R/R Richter’s transformation (CaDAnCe-101).
Ongoing clinical data from BRUKINSA® continue to demonstrate clinically meaningful benefit for patients with CLL/SLL, including data from the 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.
Presentations also included data leveraging real-world evidence and validated modeling approaches to refine understanding of real-world experience and outcomes achieved with covalent BTK inhibitors, including model analysis estimating that treating patients with BRUKINSA® instead of ibrutinib for CLL could potentially prevent cardiac deaths over a 10-year period.
An observational study examined patient-reported outcomes in U.S. patients with CLL/SLL and treated with BRUKINSA® or acalabrutinib in the community oncology setting.
Dany Habr, M.D., Senior Vice President and Head of Medical Affairs, North America & International Markets at BeOne, noted that 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.
She stated that emerging data from real-world settings suggests that BRUKINSA® may offer a more manageable side effect profile, further supporting its role as the BTKi of choice.
For additional information, visit congress.beonemedicines.com.
Contact:
Lai Wang, Ph.D., Global Head of R&D at BeOne
Dany Habr, M.D., Senior Vice President and Head of Medical Affairs, North America & International Markets at BeOne
Source: BeOne Medicines Ltd.
