BeOne Medicines Showcases Promising Hematology Pipeline Data at EHA 2026, Highlighting Advances in BTK Degradation and Time-Limited Therapies
BeOne Medicines Ltd., a global oncology company focused on developing innovative treatments for cancer and hematologic malignancies, has unveiled a series of significant clinical updates at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. The presentations highlight progress across the company’s growing hematology portfolio, including encouraging results for tacabrutideg (BGB-16673), an investigational Bruton’s tyrosine kinase (BTK) degrader, and the all-oral combination of BRUKINSA® (zanubrutinib) and BEQALZI™ (sonrotoclax).
The new findings reinforce BeOne’s strategy of advancing next-generation therapies designed to improve outcomes for patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), and mantle cell lymphoma (MCL). The data suggest that BTK degradation may represent the next evolution in targeted treatment approaches, while the company’s combination regimen continues to demonstrate the potential to support fixed-duration treatment strategies that could allow patients to achieve long-term remission without continuous therapy.
Expanding the Potential of BTK-Targeted Therapies
Over the last decade, BTK inhibitors have transformed the treatment landscape for a variety of B-cell cancers. By blocking the activity of BTK, a key signaling protein involved in the growth and survival of malignant BeOne cells, these therapies have delivered substantial clinical benefits to patients who previously had limited treatment options.
However, disease progression and treatment resistance remain ongoing challenges. Some patients eventually develop mutations that reduce the effectiveness of existing BTK inhibitors, creating a need for new therapeutic strategies.
Tacabrutideg was designed to address these limitations through a different mechanism. Rather than simply inhibiting BTK activity, the BeOne molecule promotes degradation of the BTK protein itself. By eliminating the target protein, researchers believe the therapy may overcome resistance mechanisms that limit the effectiveness of traditional BTK inhibitors.
According to Dr. Amit Agarwal, Chief Medical Officer for Hematology at BeOne Medicines, the company believes BTK degradation could represent the next major advancement in the treatment of B-cell malignancies.
He noted that the latest EHA data demonstrate durable responses among heavily pretreated patients with relapsed or refractory disease, while early evidence suggests the therapy may also have significant potential in earlier treatment settings.
At the same time, Agarwal highlighted the encouraging performance of the BeOne company’s zanubrutinib-sonrotoclax combination, which continues to generate deep and durable responses across multiple hematologic cancers.
Together, he said, these programs reflect BeOne’s ambition to redefine treatment expectations and move closer to a future in which patients may achieve long-lasting remission without the need for indefinite therapy.
Durable Responses Observed in Relapsed and Refractory CLL/SLL
One of the most closely watched presentations at EHA focused on updated findings from the ongoing Phase 1 CaDAnCe-101 study evaluating tacabrutideg in patients with relapsed or refractory CLL and SLL.
The analysis included 67 patients who had received multiple prior therapies and were considered heavily pretreated. BeOne Many participants carried high-risk disease features known to be associated with poor outcomes, including TP53 mutations, deletion 17p abnormalities, unmutated IGHV status, complex karyotypes, and mutations linked to resistance against existing BTK inhibitors.
After a median follow-up of more than two years, investigators reported encouraging efficacy outcomes.
The overall response rate reached 85.1%, indicating that the majority of patients experienced meaningful reductions in disease burden following treatment.
Responses were observed relatively quickly, with patients achieving their first response after a median of 2.8 months. Importantly, the BeOne median duration of response extended to 20.7 months, suggesting sustained disease control in a population with limited therapeutic alternatives.
Researchers also reported a 24-month progression-free survival rate of 53.8%, indicating that more than half of treated patients remained free from disease progression two years after initiating therapy.
From a safety perspective, tacabrutideg was generally well tolerated. No treatment-related deaths were reported, and investigators did not identify any unexpected toxicities. Patients who responded to treatment also demonstrated rapid and sustained improvements in cytopenias, a common complication associated with advanced hematologic malignancies.
Activity Demonstrated in Waldenström Macroglobulinemia
In addition to CLL and SLL, tacabrutideg also demonstrated encouraging activity in patients with relapsed or refractory Waldenström macroglobulinemia.
This rare form of non-Hodgkin lymphoma can be difficult to treat, particularly in patients who have exhausted multiple lines of therapy.
Among heavily pretreated patients, including those carrying BTK, CXCR4, and TP53 mutations, tacabrutideg achieved a major response rate of 76.3%. Approximately 30% of patients achieved a very good partial response, indicating substantial reductions in disease burden.
At a median follow-up of 16.6 months, the estimated 15-month progression-free survival rate reached 70.4%, suggesting durable disease control in this challenging patient population.
Expert Perspective on the Need for New Treatment Options
Dr. Stephan Stilgenbauer of Ulm University and the Comprehensive Cancer Center Ulm emphasized the significance of these findings.
He explained that treatment options become extremely limited for patients whose disease progresses after both BTK inhibitor and BCL2 inhibitor therapy. Once resistance develops to these important treatment classes, clinicians often have few effective options available.
According to Stilgenbauer, the ability of tacabrutideg to generate durable responses even among patients carrying resistance mutations and other high-risk disease characteristics suggests the therapy could become an important new option for individuals with otherwise limited prospects.
Early Success in BTK Inhibitor–Naïve Patients
Another important presentation provided the first clinical evaluation of tacabrutideg in patients who had not previously received a BTK inhibitor.
The study enrolled 54 participants across several B-cell malignancies, including CLL/SLL, mantle cell lymphoma, marginal zone lymphoma, Richter transformation, and Waldenström macroglobulinemia.
Results from evaluable CLL/SLL patients showed particularly promising activity.
The overall response rate reached 86.4%, with responses occurring rapidly. The median time to first response was again approximately 2.8 months.
Notably, none of the patients experienced disease progression during the first six months of follow-up.
Investigators also reported a favorable safety profile. No opportunistic infections, major bleeding events, or episodes of febrile neutropenia were observed, suggesting the therapy may be suitable for broader use in earlier treatment settings.
These findings support continued exploration of tacabrutideg as a potential treatment option not only for heavily pretreated patients but also for individuals earlier in the disease course.
BRUKINSA and Sonrotoclax Continue to Impress
Alongside tacabrutideg, BeOne Medicines presented several updates on the all-oral combination of BRUKINSA and sonrotoclax, referred to as the ZS regimen.
The combination pairs BTK inhibition with next-generation BCL2 inhibition, targeting two complementary pathways that support cancer cell survival.
Across multiple studies, the regimen generated rapid, deep, and durable responses while producing high rates of undetectable minimal residual disease (uMRD), an important indicator of treatment effectiveness.
Researchers believe these results support the possibility of fixed-duration treatment approaches that may allow patients to discontinue therapy after achieving deep remission.
Remarkable Outcomes in Treatment-Naïve CLL
Among previously untreated CLL patients, the ZS regimen produced particularly impressive results.
The overall response rate reached 100%, meaning every patient enrolled in the study experienced a response to treatment.
Complete responses were observed in nearly 60% of patients, while the best uMRD4 rate approached 99%.
Importantly, none of the patients who achieved undetectable minimal residual disease later reverted to detectable disease levels during follow-up.
The median time required to achieve uMRD4 was only 4.5 months, demonstrating the rapid depth of response generated by the combination.
Patients carrying high-risk TP53 mutations or deletion 17p abnormalities also achieved exceptionally high rates of minimal residual disease clearance.
At a median follow-up exceeding 34 months, no disease progression events had been reported among patients treated at the recommended Phase 2 dose, including individuals who voluntarily discontinued therapy.
Strong Performance in Relapsed and Refractory CLL
The regimen also demonstrated robust activity among patients with relapsed or refractory CLL.
At the recommended Phase 2 dose of sonrotoclax, the overall response rate again reached 100%.
More than half of patients achieved complete responses, while 85% reached undetectable minimal residual disease.
Researchers reported that no patient who achieved uMRD subsequently lost that status.
Long-term disease control remained highly encouraging, with a 36-month progression-free survival rate of 95.5% across all evaluated dose cohorts.
These findings suggest the combination may offer a highly effective treatment strategy even for patients who have previously received therapy.
Encouraging Results in Mantle Cell Lymphoma
The ZS regimen also showed substantial activity in relapsed or refractory mantle cell lymphoma, a challenging B-cell cancer that often becomes resistant to treatment.
The overall response rate reached 82%, while complete responses were observed in 59% of patients.
Perhaps most importantly, the median duration of response had not yet been reached at the time of analysis, indicating that many responses remained ongoing.
Investigators estimated that more than 78% of responding patients remained in remission after 30 months of follow-up.
Advancing the Future of B-Cell Cancer Care
The data presented at EHA 2026 underscore BeOne Medicines’ commitment to advancing innovative therapies capable of transforming treatment paradigms across B-cell malignancies.
Tacabrutideg’s ability to generate durable responses in heavily pretreated patients, including those with high-risk disease characteristics and resistance mutations, highlights the promise of BTK degradation as a novel therapeutic strategy. BeOne At the same time, the continued success of the BRUKINSA-sonrotoclax combination strengthens the case for fixed-duration treatment approaches that could provide deep remissions without lifelong therapy.
Together, these programs represent important steps toward a future where patients with CLL, SLL, WM, MCL, and other B-cell cancers may benefit from more effective, more durable, and potentially treatment-free periods of disease control. BeOne As clinical development continues, BeOne Medicines is positioning itself at the forefront of innovation in hematologic oncology, seeking to redefine standards of care and improve outcomes for patients worldwide.
About Tacabrutideg (BGB-16673)
With first-in-class and best-in-class potential, tacabrutideg is a foundational, orally administered Bruton’s tyrosine kinase (BTK) degrader. 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 Q4 2025.
Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, 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 BeOne Medicines Agency (EMA) granted tacabrutideg PRIority BeOne MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
About BEQALZI™ (sonrotoclax)
BEQALZI™ (bee-KAHL-zee; 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.
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.
With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.
The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.
