SAN CARLOS, Calif. | May 29, 2026
BeOne Medicines presented groundbreaking long-term data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating that BRUKINSA® (zanubrutinib) continues to deliver durable disease control in patients with chronic lymphocytic leukemia (CLL). The updated findings from the Phase 3 SEQUOIA study represent the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, reinforcing BRUKINSA’s position as a foundational therapy. In addition, new data from the combination of BRUKINSA and BEQALZI™ (sonrotoclax) showcased unprecedented rates of undetectable minimal residual disease (uMRD), highlighting the potential for future time-limited treatment strategies in CLL.
BRUKINSA Delivers Unprecedented Long-Term Disease Control
BeOne Medicines reported that after a median follow-up of more than 84 months, patients treated with BRUKINSA achieved a remarkable 78-month progression-free survival (PFS) rate of 71.8%, compared with 31.0% for patients receiving bendamustine plus rituximab. COVID-adjusted analyses further strengthened the findings, with a PFS rate of 74.6% for BRUKINSA-treated patients. The benefits extended across both mutated and unmutated IGHV patient populations, demonstrating consistent efficacy in high-risk disease subgroups. The study also showed a significant advantage in time to next treatment, highlighting the long-term clinical impact of choosing BRUKINSA as first-line therapy. Importantly, the safety profile remained consistent with previous studies, with no new safety concerns identified during the extended follow-up period.
Real-World Evidence Reinforces BRUKINSA Leadership in CLL
Complementing the clinical trial data, BeOne Medicines presented findings from multiple real-world studies involving more than 250,000 patients, further validating BRUKINSA’s effectiveness and safety in routine clinical practice. In a Medicare-based analysis of over 10,500 frontline CLL patients, BRUKINSA was associated with significantly lower risks of death, treatment discontinuation, or progression compared with both ibrutinib and acalabrutinib. Another large claims-based study involving nearly 17,000 treatment-naïve patients demonstrated superior overall survival and longer time to next treatment with BRUKINSA. Additionally, a retrospective analysis of more than 233,000 patients showed that BRUKINSA had the lowest one-year incidence of atrial fibrillation among approved BTK inhibitors, supporting its favorable cardiovascular safety profile.
Advertisement
BRUKINSA Plus Sonrotoclax Raises the Bar for Time-Limited Therapy
BeOne also highlighted promising Phase 1/1b data evaluating the all-oral combination of BRUKINSA and sonrotoclax (ZS) in treatment-naïve CLL patients. The regimen achieved a 100% overall response rate, with complete responses observed in nearly 60% of patients. Most notably, the combination delivered a 98.8% uMRD4 rate, representing one of the highest reported rates of deep molecular response in CLL. Responses were equally impressive in patients with high-risk genetic features, including TP53 mutations and del(17p). The median time to achieve uMRD4 was only 4.5 months, and no disease progression events were reported at the recommended Phase 2 dose. These results suggest that BRUKINSA-based combinations may enable highly effective fixed-duration treatment approaches while maintaining durable disease control..
The latest ASCO presentations further strengthen BeOne Medicines’ leadership in hematologic oncology and demonstrate the growing impact of its expanding portfolio. With BRUKINSA establishing a new standard for long-term disease management and sonrotoclax-based combinations showing transformative potential, the company continues to advance innovative treatment strategies aimed at improving outcomes for patients living with CLL.
Source: BeOne Medicines press release
