BeOne Medicines showcases sustained leukemia control with long-term Brukinsa data

BeOne Medicines (NASDAQ:ONC) is moving to advance the treatment paradigm for chronic lymphocytic leukemia (CLL) with extensive long-term follow-up data slated for the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

The global oncology specialist showcased results from its landmark Phase 3 SEQUOIA study of the Bruton's tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), alongside massive real-world data and emerging next-generation combination therapies.

The 78-month follow-up data from the SEQUOIA trial represents the longest reported tracking period for a next-generation BTK inhibitor in first-line CLL.

After a median follow-up of 84.01 months, Brukinsa demonstrated significant progression-free survival (PFS) benefits over a traditional bendamustine-rituximab (BR) chemoimmunotherapy regimen in treatment-naive patients.

The study showed a 78-month progression-free survival rate of 71.8% for patients treated with Brukinsa, compared to 31% for those in the chemoimmunotherapy arm.

When adjusted for the global impact of COVID-19, the PFS rate for Brukinsa rose to 74.6%, maintaining a substantial gap over the 31.4% recorded for the control group.

The trial also demonstrated durable outcomes across high-risk patient subgroups.

For patients with unmutated IGHV, the 78-month progression-free survival rate reached 70.4% under Brukinsa therapy versus 17.4% for the comparison group.

For patients with mutated IGHV, the rate reached 81.8% for the Brukinsa arm compared to 45.1% for the control group.

Time to next treatment also heavily favored the targeted therapy, yielding a statistically significant hazard ratio of 0.24.

Beyond initial disease control, the trial provided insights into second-line progression.

The 78-month second progression-free survival (PFS2) rate reached 81.3% for Brukinsa, compared to 74.4% for BR, which increased to 84.7% for Brukinsa upon COVID-19 adjustment.

Of the 26 Brukinsa-treated patients who experienced disease progression, half transitioned to subsequent salvage therapy utilizing BCL2 inhibitors.

Among those patients, 69.2% had not experienced further disease progression after more than three years of follow-up monitoring.

The overall safety profile remained consistent with historical trials, revealing no new safety signals.