BeOne Medicines Highlights Long-Term BRUKINSA Benefits in Older CLL Patients at EHA 2026
BeOne Medicines Ltd., a global oncology company dedicated to advancing innovative cancer therapies, has announced the presentation of significant new clinical and real-world evidence supporting the long-term use of BRUKINSA (zanubrutinib) in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The findings, which will be showcased at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden, reinforce BRUKINSA’s position as a leading Bruton’s tyrosine kinase (BTK) inhibitor and provide important new insights into treatment outcomes among elderly patients, particularly those aged 80 years and older.
The data include results from one of the largest and longest-running analyses of treatment-naïve CLL patients in this advanced age group. With nearly six and a half years of follow-up, the findings demonstrate that BRUKINSA continues to deliver durable disease control, favorable survival outcomes, and a manageable safety profile, even among patients with high-risk disease characteristics.
Addressing a Critical Need in an Aging CLL Population
Chronic lymphocytic leukemia is the most common form of leukemia in adults and is primarily a disease of older individuals. The median age at diagnosis is approximately 70 years, and most patients begin treatment in their mid-70s. Despite this reality, patients aged 80 and older have historically been underrepresented in major clinical trials, leaving physicians with limited long-term evidence to guide treatment decisions for one of the most vulnerable patient populations.
According to Dr. Amit Agarwal, Chief Medical Officer for Hematology at BeOne Medicines, this evidence gap has been a longstanding challenge in CLL management.
He noted that while physicians routinely treat patients in their 70s and 80s, many pivotal clinical studies have focused on younger and healthier populations. The newly presented data help close that gap by demonstrating that the benefits of BRUKINSA extend well into advanced age, including among patients carrying high-risk genetic mutations and disease features.
Dr. Agarwal emphasized that the favorable safety profile of BRUKINSA, particularly the low incidence of atrial fibrillation observed across both clinical trials and real-world studies, is especially important in older patients who often have underlying cardiovascular conditions. These BeOne findings, he said, further support BRUKINSA’s role as a foundational BTK inhibitor in first-line CLL treatment.
SEQUOIA Analysis Demonstrates Durable Responses in Patients Aged 80 and Older
BeOne of the key presentations at EHA 2026 focuses on a subgroup analysis from the Phase 3 SEQUOIA trial, examining outcomes among patients aged 80 years and older who received BRUKINSA as first-line therapy.
The analysis included 38 elderly patients with a median age of 81 years, ranging from 80 to 87 years old. Importantly, the BeOne study population represented a particularly challenging group, with many patients carrying adverse prognostic markers. More than one-third had deletion 17p or TP53 mutations, while nearly 58% had unmutated IGHV status, both of which are associated with poorer outcomes.
Despite these high-risk features, BRUKINSA demonstrated remarkable long-term efficacy after a median follow-up period of 78.8 months.
Among the most notable findings:
- The overall response rate reached 100%.
- Complete responses were achieved in 18.4% of patients.
- Progression-free survival at 72 months was 63.8%.
- Overall survival at 72 months reached 75.9%.
- More than one-third of patients remained on BRUKINSA treatment after six years.
The BeOne safety profile remained consistent with previous studies, with no unexpected adverse events emerging during long-term follow-up. Researchers noted that treatment tolerability supports prolonged use of BRUKINSA even in very elderly patients.
Experts Highlight Importance of Long-Term Data
Dr. Alessandra Tedeschi, Medical Director of the Department of Hematology at the Niguarda Cancer Center in Milan, Italy, underscored the significance of the findings.
She explained that treating patients in their 80s often requires balancing disease control against competing health concerns, including cardiovascular disease, diabetes, and other age-related conditions. Historically, physicians have lacked robust long-term evidence specifically focused on this age group.
According to Dr. Tedeschi, the durability of response observed with zanubrutinib, combined with its manageable safety profile, provides clinicians with valuable information when making treatment decisions for elderly patients. The BeOne findings suggest that age alone should not be a barrier to achieving meaningful long-term disease control.
Longest Follow-Up Yet for a Next-Generation BTK Inhibitor
The BeOne elderly subgroup analysis is being presented alongside updated results from the broader SEQUOIA Phase 3 study, which now offers 78 months of follow-up—the longest reported dataset for a next-generation BTK inhibitor in first-line CLL treatment.
The BeOne extended analysis continues to demonstrate substantial advantages for BRUKINSA compared with the traditional chemoimmunotherapy regimen of bendamustine plus rituximab (BR).
Key efficacy findings include:
- Progression-free survival at 78 months was 71.8% for BRUKINSA compared with 31.0% for bendamustine-rituximab.
- When adjusted for COVID-related factors, progression-free survival increased to 74.6% for BRUKINSA versus 31.4% for BR.
- Among patients with unmutated IGHV, progression-free survival reached 70.4% with BRUKINSA compared with only 17.4% for BR.
- In patients with mutated IGHV, progression-free survival was 81.8% versus 45.1%, respectively.
- Progression-free survival after subsequent therapy (PFS2) also favored BRUKINSA.
Researchers additionally observed that among BRUKINSA-treated patients whose disease progressed, BeOne many responded successfully to later treatment with BCL2 inhibitor-based therapies. More than two-thirds of those patients remained progression-free for over three years after initiating salvage therapy.
The data also showed that patients receiving BRUKINSA experienced longer times before requiring additional treatment, a key indicator of durable disease control.
Real-World Evidence Supports Clinical Trial Findings
Beyond clinical trial data, BeOne Medicines will present several large-scale real-world studies involving more than 250,000 patients.
These analyses provide additional support for BRUKINSA’s effectiveness and safety in everyday clinical practice.
One study evaluated 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 subsequent therapy compared with those receiving either ibrutinib or acalabrutinib.
Importantly, these benefits were observed consistently across different age groups, including older patients.
A second real-world study involving nearly 17,000 treatment-naïve CLL patients found that BRUKINSA was associated with longer overall survival and a longer time before requiring another line of therapy.
Lower Rates of Atrial Fibrillation Observed
Cardiovascular safety remains a critical consideration in CLL treatment, particularly among elderly patients.
A retrospective analysis involving more than 233,000 newly diagnosed CLL patients compared rates of atrial fibrillation among different BTK inhibitors.
The findings showed:
- BRUKINSA: 11% one-year atrial fibrillation rate
- Acalabrutinib: 13%
- Ibrutinib: 16%
Given that the prevalence of atrial fibrillation rises significantly with age and that many CLL patients already have cardiovascular comorbidities, BeOne these results may have important implications for treatment selection in routine clinical practice.
Understanding What Matters Most to Patients
In addition to clinical and real-world outcomes, BeOne Medicines also explored how patients make treatment decisions.
Researchers used artificial intelligence-powered semantic analysis to examine more than 44,000 online conversations involving nearly 2,700 CLL patients across France, Germany, Italy, Spain, and the United Kingdom.
The analysis identified several recurring themes influencing treatment choices.
Safety emerged as one of the most frequently discussed factors, appearing in between 22% and 42% of patient conversations. Disease severity and treatment effectiveness were also consistently cited across all five countries.
Patients often defined effectiveness in practical terms, such as achieving remission, experiencing rapid responses, maintaining disease control, and returning to normal daily activities.
Interestingly, treatment duration was rarely mentioned as a primary consideration, appearing in fewer than 5% of conversations.
The study also revealed that shared decision-making remains limited. Only a small percentage of patients explicitly reported active involvement in selecting their treatment, suggesting opportunities for improved patient engagement and communication.
Reinforcing BRUKINSA’s Role in First-Line CLL Treatment
Collectively, the data presented at EHA 2026 strengthen the growing body of evidence supporting BRUKINSA as a foundational therapy for chronic lymphocytic leukemia. From long-term clinical trial outcomes and elderly patient analyses to large-scale real-world studies and patient preference research, the findings consistently demonstrate durable efficacy, strong survival outcomes, and a favorable safety profile.
For physicians treating an increasingly older CLL population, these results provide valuable reassurance that effective long-term disease control can be achieved even in patients over 80 years of age. BeOne As treatment strategies continue to evolve, the evidence presented by BeOne Medicines highlights the potential of BRUKINSA to remain a central component of frontline CLL care for years to come.
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.
