BeOne Medicines Showcases Long-Term BRUKINSA Success and Next-Generation CLL Treatment Advances at ASCO 2026
BeOne Medicines Ltd., a global oncology company dedicated to developing innovative cancer therapies, is presenting extensive new data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting that further strengthens the role of BRUKINSA® (zanubrutinib) as a foundational treatment for chronic lymphocytic leukemia (CLL). The company’s latest findings include long-term follow-up from the pivotal SEQUOIA study, real-world evidence involving more than 250,000 patients, and promising results from emerging combination strategies designed to transform future treatment approaches.
The data highlight the continued evolution of CLL management, demonstrating that BRUKINSA delivers durable disease control over many years while maintaining a favorable safety profile. In addition, BeOne showcased encouraging results from the development of BEQALZI™ (sonrotoclax), a next-generation BCL2 inhibitor recently approved by the U.S. Food and Drug Administration, particularly when used in combination with BRUKINSA. Together, these findings reinforce the company’s vision of building a comprehensive hematology portfolio capable of addressing both current and future patient needs.
Long-Term Disease Control Remains Critical in CLL
Chronic lymphocytic leukemia is the most common form of adult leukemia in many parts of the world. Because it is generally a slow-growing disease, patients often live with CLL for many years and may require long-term treatment strategies that provide sustained disease control while preserving quality of life.
As treatment options continue to expand, physicians increasingly focus not only on achieving an initial response but also on ensuring that patients remain progression-free for extended periods. Long-term efficacy data therefore play a crucial role in helping clinicians select therapies that can deliver durable benefits over the course of a patient’s disease journey.
According to Amit Agarwal, M.D., Ph.D., Chief Medical Officer for Hematology at BeOne Medicines, the company’s ASCO presentations demonstrate that BRUKINSA continues to provide reliable disease control over the long term, giving both physicians and patients confidence in treatment decisions.
He emphasized that the latest analyses, including extensive real-world evidence, support BRUKINSA’s position as a best-in-class Bruton’s tyrosine kinase (BTK) inhibitor. The findings also illustrate how BRUKINSA serves as the foundation for BeOne’s broader hematology strategy, which includes innovative combination regimens and next-generation targeted therapies such as the company’s investigational BTK degrader, tacabrutideg.
SEQUOIA Trial Delivers the Longest Follow-Up for a Next-Generation BTK Inhibitor
One of the highlights of BeOne’s ASCO presentation is the latest update from the Phase 3 SEQUOIA study, which now provides the longest reported follow-up for a next-generation BTK inhibitor used in the first-line treatment of CLL.
The trial evaluated BRUKINSA in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL) and compared outcomes against the traditional chemoimmunotherapy regimen of bendamustine plus rituximab (BR).
After a median follow-up of 84.01 months—approximately seven years—BRUKINSA continued to demonstrate substantial advantages over BR across multiple efficacy measures.
The study reported a progression-free survival (PFS) rate of 71.8% at 78 months for patients receiving BRUKINSA, compared with 31.0% for those treated with bendamustine-rituximab. When adjusted for COVID-related events, progression-free survival remained highly favorable, reaching 74.6% for BRUKINSA versus 31.4% for BR.
These outcomes represent some of the strongest long-term progression-free survival results ever reported for a BTK inhibitor in frontline CLL treatment.
Benefits Extend Across Key Patient Subgroups
The SEQUOIA findings demonstrated that BRUKINSA’s benefits were consistent across clinically important patient populations, including those with varying immunoglobulin heavy-chain variable region (IGHV) mutation status.
Among patients with unmutated IGHV—a group traditionally associated with poorer outcomes—the progression-free survival rate at 78 months reached 70.4% with BRUKINSA compared with only 17.4% for bendamustine-rituximab.
Patients with mutated IGHV also experienced meaningful benefits, with progression-free survival rates of 81.8% for BRUKINSA versus 45.1% for the comparator regimen.
The study additionally examined progression-free survival after subsequent therapy, known as PFS2, which measures disease progression beyond first-line treatment. At 78 months, PFS2 rates reached 81.3% for BRUKINSA and 74.4% for BR, while COVID-adjusted analyses showed rates of 84.7% and 76.4%, respectively.
These findings suggest that the advantages of BRUKINSA extend beyond initial disease control and may influence outcomes across multiple lines of treatment.
Delaying the Need for Additional Therapy
Another important measure in CLL treatment is time to next treatment (TTNT), which reflects how long patients can remain on their initial therapy before requiring another intervention.
The SEQUOIA trial demonstrated a significant advantage for BRUKINSA, with patients experiencing a substantially longer time before needing additional treatment compared with those receiving bendamustine-rituximab.
Furthermore, among the relatively small number of BRUKINSA-treated patients who experienced disease progression, many responded well to subsequent therapies. Approximately half received BCL2 inhibitor-based salvage treatments, and nearly 70% remained progression-free after more than three additional years of follow-up.
Importantly, the long-term safety profile of BRUKINSA remained consistent with previous studies, with no new safety concerns identified despite more than seven years of observation.
Experts Highlight Confidence in Long-Term Treatment Decisions
The importance of these findings was emphasized by Professor Constantine Tam, Head of the Lymphoma Service at Alfred Health and Professor of Haematology at Monash University.
He noted that patients living with CLL often prioritize maintaining disease control throughout their lifetime rather than focusing solely on short-term treatment outcomes. According to Tam, the extended follow-up from SEQUOIA provides compelling evidence that zanubrutinib can deliver sustained disease management over many years, offering clinicians and patients greater confidence when making first-line treatment decisions.
The ability to demonstrate long-term effectiveness is increasingly important as treatment expectations continue to evolve and patients seek therapies capable of delivering durable benefits with manageable safety profiles.
Real-World Evidence Reinforces BRUKINSA’s Position
In addition to clinical trial results, BeOne presented multiple real-world analyses that further support BRUKINSA’s performance in everyday medical practice.
One study examined outcomes among 10,523 Medicare beneficiaries diagnosed with CLL or SLL who received frontline treatment with a BTK inhibitor. Patients treated with BRUKINSA experienced a significantly lower risk of death, treatment discontinuation, or progression to a subsequent therapy line compared with those receiving either ibrutinib or acalabrutinib.
A second analysis involving 16,788 treatment-naïve CLL patients from the Komodo healthcare database found that BRUKINSA was associated with longer time to next treatment and improved overall survival compared with competing BTK inhibitors.
Perhaps most notably, a retrospective study involving 233,362 newly diagnosed CLL patients revealed lower rates of atrial fibrillation among BRUKINSA-treated patients. Within one year of treatment initiation, atrial fibrillation occurred in 11% of BRUKINSA recipients compared with 13% for acalabrutinib and 16% for ibrutinib.
These large-scale analyses provide important validation of clinical trial findings and suggest that BRUKINSA’s benefits translate effectively into routine clinical practice.
Sonrotoclax Combination Shows Promise for Time-Limited Treatment
While BRUKINSA continues to establish itself as a long-term treatment cornerstone, BeOne medicines is also exploring future strategies designed to achieve deep remissions with finite treatment durations.
Data from a Phase 1/1b study evaluating BRUKINSA in combination with sonrotoclax demonstrated particularly encouraging results in treatment-naïve CLL and SLL patients.
The all-oral regimen achieved an overall response rate of 100%, with nearly 60% of patients achieving complete responses. The combination also generated exceptionally high rates of undetectable minimal residual disease (uMRD), a key marker associated with deep and durable treatment responses.
The best uMRD4 rate reached 98.8%, while patients with high-risk genetic features, including TP53 mutations or deletion 17p abnormalities, achieved uMRD rates exceeding 90%.
Notably, no patients who achieved uMRD4 reverted to detectable disease, and no disease progression events were observed at the recommended Phase 2 dose of sonrotoclax, even among patients who voluntarily discontinued therapy.
The median time required to achieve uMRD4 was just 4.5 months, highlighting the rapid depth of response produced by the combination.
Expanding a Broad Hematology Franchise
The data presented at ASCO 2026 underscore BeOne Medicines’ ambition to redefine expectations for patients living with chronic lymphocytic leukemia. Through long-term evidence supporting BRUKINSA, extensive real-world validation, and innovative next-generation combinations such as BRUKINSA plus sonrotoclax, the company continues to expand its leadership in hematologic malignancies.
These findings will also be featured at the 2026 European Hematology Association Congress, where BeOne plans to present more than 30 additional datasets spanning its growing oncology and hematology portfolio.
As treatment standards continue to evolve, the company’s research efforts suggest that future CLL management may increasingly combine durable disease control with the possibility of deep remissions and time-limited therapy, offering patients new hope for improved long-term outcomes.
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.
About BEQALZI™ (sonrotoclax)
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.
About Tacabrutideg (BGB-16673)
Tacabrutideg is a foundational and potential first-in-class and best-in-class orally available Bruton’s tyrosine kinase (BTK) degrader. With 1,200+ patients dosed to date in an extensive global clinical development program, tacabrutideg is the most advanced BTK degrader in the clinic. 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 Medicine’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 MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
