SAN CARLOS, CALIF. -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced new data from its foundational hematology franchise at the 2026 European Hematology Association (EHA) Congress in Stockholm. Updated results from tacabrutideg (BGB-16673), a potential best-in-class Bruton’s tyrosine kinase (BTK) degrader, demonstrated durable responses in pretreated relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with early activity also seen in BTK inhibitor-naïve patients. These data are complemented by results from the all-oral combination of BRUKINSA® (zanubrutinib) plus next-generation BCL2 inhibitor BEQALZI™ (sonrotoclax; ZS), which continue to demonstrate rapid, deep, durable responses across multiple B-cell malignancies.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
“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 show durable responses with tacabrutideg in heavily pretreated R/R CLL/SLL and R/R WM (Oral Presentation: S152; June 14, 11:00 AM-12:15 PM CEST; Poster Presentation: PS2033; June 13, 2026, 6:45-7:45 PM CEST)
The oral presentation, which was selected for inclusion in the EHA Press Program, will highlight data from 67 patients with R/R CLL/SLL treated with tacabrutideg across the different dose levels (50-500 mg), including patients with high-risk disease features (del(17p)/TP53 mutation, unmutated IGHV, complex karyotype, and BTK inhibitor resistance mutations). With a median study follow-up of 25.4 (range, 0.3-40.1) months, the analysis showed:

·Overall response rate (ORR): 85.1%
·Median time to first response (TTFR): 2.8 months (range, 2.0-19.4)
·Median duration of response (DOR): 20.7 months (range, 0-27.6)
·24-month progression-free survival (PFS) rate: 53.8% (95% CI, 38.8%-66.6%)
·Safety: tacabrutideg was generally well tolerated in this heavily pretreated population with no treatment-related deaths and no new toxicities identified; patients with treatment response had rapid and sustained cytopenia improvement

In patients with R/R Waldenstrom macroglobulinemia (WM), tacabrutideg showed substantial responses in heavily pretreated patients, including those bearing BTK, CXCR4, and TP53 mutations, with major response rate (MRR) of 76.3% and very good partial response (VGPR) of 30.2% and a 15-month PFS rate of 70.4% (95% CI, 52.6-82.5) at a median PFS follow-up of 16.6 months.

Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Center Ulm (CCCU), Head of the Early Clinical Trials Unit (ECTU), and Head of the Division of CLL Dept. of Internal Medicine III at Ulm University, said:
“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.”

First report of tacabrutideg in BTK inhibitor-naïve patients shows potential for improved efficacy in earlier treatment lines (Poster Presentation: PS1693; June 13, 2026, 6:45-7:45 PM CEST)
In the first clinical evaluation of tacabrutideg in patients who had not previously received a BTK inhibitor (N=54; CLL/SLL, n=29; mantle cell lymphoma [MCL], n=8; marginal zone lymphoma, n=10; Richter transformation, n=2; WM, n=5), tacabrutideg was well tolerated and showed promising and rapid antitumor activity. In 22 evaluable patients with CLL/SLL with median follow-up of 8.2 (range: 0.4-12.8) months, the study shows:

·ORR: 86.4% Median TTFR: 2.8 (range, 2.7-5.6) months
·At 6 months, none of the patients had progressed
·Safety: tacabrutideg was generally well tolerated with no reported opportunistic infections, major hemorrhage or febrile neutropenia

Rapid, deep, and durable responses with ZS reinforce the potential to redefine time-limited treatment across CLL and MCL (Multiple Presentations)
Across multiple presentations at EHA 2026, the all-oral ZS combination demonstrated rapid, deep, and durable responses across both treatment-naïve and relapsed/refractory settings. These data highlight the ability of ZS to drive high rates of undetectable minimal residual disease (uMRD) and sustained disease control regardless of risk factors reinforcing its potential to redefine expectations for fixed-duration, time-limited therapy in B-cell malignancies.

In treatment-naïve CLL (Oral Presentation: S145; June 12, 2026; 5:15-6:30 PM CEST):

·ORR: 100%, with complete responses in 59.5% of patients
·Best uMRD4 rate: 98.8%
-No patient that achieved uMRD4 reverted to uMRD positivity
·Best uMRD in patients with TP53 mutation/del(17p): 92.9% across 2 dose levels
·Median time from combination start to uMRD4: 4.5 months
·At a median follow-up of 34.1 months, no disease progression events were observed at the recommended Phase 2 dose of 320mg, including patients who electively discontinued therapy

In R/R CLL (Poster Presentation: PS1697; June 13, 2026, 6:45-7:45 PM CEST), at the 320mg (RP2D) of sonrotoclax:

·ORR: 100%, with complete responses in 52% of patients
·Best uMRD4 rate: 85%
-No patient that achieved uMRD4 reverted to uMRD positivity
·36-month PFS: 95.5% (95% CI, 83.2%-98.9%) across all dose cohorts at a median follow-up of 40.6 months (range, 10.2-60.6 months)

In R/R MCL (Poster Presentation: PF933; June 12, 2026, 6:45-7:45 PM CEST), at the 320mg (RP2D) of sonrotoclax:

·ORR: 82%, with complete responses in 59% of patients
·Median duration of response (DOR): not reached
·30-mo DOR: 78.3% (95% CI, 51.3.%-91.4%)