Brukinsa provides long-term disease control in chronic lymphocytic leukemia

Brukinsa (zanubrutinib) shows long-term benefit for patients with chronic lymphocytic leukemia (CLL), according to results released recently at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

Chronic lymphocytic leukemia is a slow-growing type of B-cell malignancy that results in the overgrowth of white blood cells in the bone marrow. It is the most common leukemia in adults, and it typically affects older white men with a median age at diagnosis of 70. In the United States, there will be about 22,760 new cases of CLL and about 4,350 deaths from CLL, according to the American Cancer Society.

Developed by BeOne Medicines, Brukinsa is an oral medication and an inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a signaling molecule of the B-cell antigen receptor and cytokine receptor pathways. In nonclinical studies, Brukinsa inhibited growth of malignant B cells and reduced tumor growth.

Brukinsa is indicated for the treatment of several cancers, including mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and Waldenström’s macroglobulinemia. The wholesale acquisition cost, or list price, for a 30-day supply of Brukinsa is $16,673 per bottle, before discounts or rebates, according to a company spokesperson. The medication is not priced differentially by indication. Patients with commercial insurance may be eligible for a $0 copay for Brukinsa, with an annual limit of $25,000.

In the SEQUOIA trial, after a median follow-up of 84 months, Brukinsa continued to show benefit over the bendamustine-rituximab combination in patients with treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma. The 78-month progression-free survival was 71.8% in the Brukinsa compared with 31% for bendamustine-rituximab. The benefit was consistent over the various subgroups of patients, including those of older age and those with a mutation of IGHV, a biomarker used to assess disease progression.

SEQUOIA is a phase 3 that randomized 241 patients to receive Brukinsa and 238 patients to receive bendamustine-rituximab.

“In an indolent disease like CLL, many patients value maintaining disease control over the course of their life, not just in the first year or two of treatment. The continued long-term follow-up from SEQUOIA shows that zanubrutinib can deliver sustained disease control,” Constantine Tam, M.B.B.S., M.D., head of Lymphoma Service at Alfred Health and Professor of Haematology at Monash University in Melbourne, Australia, said in a news release.

In addition to the SEQUOIA data, an analysis of real-world data from 10,523 Medicare patients with CLL or SLL who were treated with a BTK was also presented at ASCO. Patients treated with Brukinsa statistically significantly lower risk of death, advancing to the next line of treatment, or discontinuing treatment than those on Imbruvica (ibrutinib) or Calquence (acalabrutinib). Similar results were observed across age subgroups.

Deidentified data from the Medicare Fee-for-Service database were used for this retrospective, observational, cohort study. Outcomes included real-world time to treatment discontinuation or death, time to next treatment, and overall survival. At 12 months and 24 months, patients treated with Brukinsa had a higher probability of survival (90.8% at 12 months and 85.9% at 24 months) than those treated with Calquence (86.9% at 12 months and 79.7% at 24 months) and Imbruvica (84.8% at 12 months and 75.4% at 24 months).

In a separate analysis of claims from US Symphony Health PatientSource, newly diagnosed adults with CLL/SLL treated with Brukinsa had a lower rate of atrial fibrillation within the first year: 11% compared with 13% for those treated with Calquence and 16% for those treated with Imbruvica. Research has found an association between BTK inhibitors and cardiovascular side effects because of effects on other kinases that protect heart cells and fibrosis.