Six-Year SEQUOIA Data Highlight Durable BRUKINSA Benefit in CLL Patients Aged 80 and Older

BeOne Medicines has presented new six-year follow-up data from the Phase 3 SEQUOIA trial (NCT03336333) at the 2026 European Hematology Association Congress, highlighting durable benefit of BRUKINSA® (zanubrutinib) in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients aged 80 years and older.

This analysis provides rare prospective long-term data in an underrepresented population and showed that nearly two-thirds of patients remained progression-free at six years despite advanced age and high-risk disease features.

Clinical Outcomes and Safety

Among 38 treatment-naïve patients aged 80 years and older (median age 81), BRUKINSA achieved a 100% overall response rate, including complete responses in 18.4% of patients. At 72 months, progression-free survival was 63.8% and overall survival was 75.9%, while 36.8% of patients remained on treatment. The safety profile remained consistent with previous BRUKINSA studies, with no new safety signals observed during extended follow-up.

Broader SEQUOIA Dataset Reinforces Benefit

Updated 78-month results from the overall SEQUOIA study further supported BRUKINSA’s long-term efficacy. Progression-free survival was 71.8% with BRUKINSA compared with 31.0% for bendamustine plus rituximab. Benefits were observed across molecular subgroups, including patients with both mutated and unmutated IGHV status.

Among patients who experienced disease progression while receiving BRUKINSA, subsequent treatment with BCL2 inhibitors provided durable disease control extending beyond three years, supporting the effectiveness of sequential targeted therapy approaches.

Real-World Evidence Strengthens Positioning

Complementary real-world analyses involving large U.S. datasets further supported BRUKINSA’s clinical profile. Medicare data linked BRUKINSA to lower risks of death, discontinuation, or progression compared with ibrutinib and acalabrutinib, while a separate analysis reported lower rates of atrial fibrillation among BRUKINSA-treated patients.

Patient Perspectives and Shared Decision-Making

An AI-based analysis of 44,451 online patient discussions across Europe identified safety, disease severity, and treatment effectiveness as the primary factors influencing frontline treatment decisions in CLL. Treatment duration was cited less frequently, suggesting that patients prioritize disease control and tolerability when evaluating treatment options.

The findings also suggested that patients are not consistently involved in treatment decisions, highlighting opportunities to strengthen shared decision-making in CLL care.

Implications for Clinical Practice

The six-year SEQUOIA results provide rare prospective evidence of durable benefit and manageable safety in patients aged 80 years and older, a population historically underrepresented in pivotal clinical trials.

Together with supportive real-world findings and patient preference insights, the data further strengthen the evidence base for BRUKINSA in frontline CLL.

The findings add to the growing body of long-term evidence supporting BRUKINSA in CLL, particularly among older patients who often face greater treatment complexity and have been less frequently represented in clinical research.

Reference

BeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA Benefit – BeOne Medicines NASDAQ