Announcement • 6h
BeOne Medicines Announces New Data From Foundational Hematology Franchise At EHA 2026
BeOne Medicines 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. 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. 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. 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: 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, 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, 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%). Tacabrutideg is the most advanced BTK degrader in the clinic with 1,200+ 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 the Fourth Quarter 2025. Tacabrutideg 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 tacabrutideg 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 tacabrutideg PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor. BEQALZI (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in 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, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,500 patients have been enrolled across the broad sonrotoclax global development program. BEQALZI is approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a BTK inhibitor. It is also approved in China for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor. 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.