Stockholm, Sweden — June 12, 2026 — Leads & Copy — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today unveiled significant new data from its hematology franchise at the 2026 European Hematology Association (EHA) Congress in Stockholm. The updated results for tacabrutideg (BGB-16673), a potential best-in-class Bruton’s tyrosine kinase (BTK) degrader, showcased durable responses in patients with pretreated relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Early activity was also observed in patients who have not previously received a BTK inhibitor.
These findings were further supported by results from the all-oral combination of BRUKINSA® (zanubrutinib) plus the next-generation BCL2 inhibitor BEQALZI™ (sonrotoclax; ZS). This combination continues to demonstrate rapid, deep, and durable responses across multiple B-cell malignancies.
Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, commented on the significance of the data, stating, “BTK inhibition has reshaped the treatment of B-cell cancers, and we believe degradation is the next leap forward. At EHA, tacabrutideg is showing durable responses in heavily pretreated CLL, where patients have limited options, with early data suggesting potential in earlier lines of treatment. At the same time, the depth and consistency of responses we’re seeing with our ZS combination supports its potential to become the foundation of time-limited therapy, bringing us closer to a future where durable, treatment-free remission is possible. Together, these data reflect our ambition to define the next era of care in B-cell malignancies.”
Updated CaDAnCe-101 data presented highlighted durable responses with tacabrutideg in heavily pretreated R/R CLL/SLL and R/R Waldenstrom macroglobulinemia (WM). The analysis, which included 67 patients with R/R CLL/SLL treated with tacabrutideg across various dose levels and patients with high-risk disease features, showed an overall response rate (ORR) of 85.1%. The median time to first response (TTFR) was 2.8 months, with a median duration of response (DOR) of 20.7 months. The 24-month progression-free survival (PFS) rate was 53.8%. Tacabrutideg was generally well tolerated in this population, with no treatment-related deaths or new toxicities identified, and patients experiencing treatment response showed rapid and sustained cytopenia improvement. In R/R WM patients, tacabrutideg demonstrated substantial responses, with a major response rate (MRR) of 76.3% and a very good partial response (VGPR) of 30.2%, alongside a 15-month PFS rate of 70.4%.
Stephan Stilgenbauer, Professor of Medicine at Ulm University, noted the promise of tacabrutideg, particularly for patients with limited treatment options, stating, “Once patients with relapsed or refractory CLL progress after both BTK and BCL2 inhibitors, treatment options become extremely limited. In this study, tacabrutideg, which is designed to degrade BTK rather than inhibit it, achieved durable responses even in patients with high-risk clinical and biological characteristics, such as resistance mutations. These findings suggest a promising new approach for patients who currently have few effective therapies available.”
A first report on tacabrutideg in BTK inhibitor–naïve patients indicated potential for improved efficacy in earlier treatment lines. In this evaluation of 54 patients across various B-cell malignancies, tacabrutideg was well tolerated and showed promising and rapid antitumor activity. In 22 evaluable CLL/SLL patients, the ORR was 86.4%, with no progression observed at six months. Tacabrutideg was generally well tolerated with no reported opportunistic infections, major hemorrhage, or febrile neutropenia.
Across multiple presentations, the all-oral ZS combination reinforced its potential to redefine time-limited treatment in CLL and mantle cell lymphoma (MCL). The combination demonstrated rapid, deep, and durable responses in both treatment-naïve and R/R settings, driving high rates of undetectable minimal residual disease (uMRD) and sustained disease control. In treatment-naïve CLL, the ORR was 100%, with a best uMRD4 rate of 98.8%. No patient achieving uMRD4 reverted to uMRD positivity. In R/R CLL, the ORR was 100%, with a best uMRD4 rate of 85%, and a 36-month PFS of 95.5%. For R/R MCL, the ORR was 82%, with a 30-month DOR of 78.3%.
Tacabrutideg (BGB-16673) is an orally administered BTK degrader with first-in-class and best-in-class potential, designed to promote the degradation of both wildtype and mutant forms of BTK. It has received Fast Track Designation from the FDA for R/R CLL/SLL and R/R MCL, and PRIME designation from the EMA for WM. BEQALZI™ (sonrotoclax) is a next-generation BCL2 inhibitor with a potent and specific profile, approved in the U.S. and China for R/R MCL and approved in China for CLL/SLL. BRUKINSA® (zanubrutinib) is an orally available BTK inhibitor designed for complete and sustained inhibition of BTK, with broad global approvals and over 290,000 patients treated worldwide.
Source: BeOne Medicines Ltd.
