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5-Year Follow-Up: Zanubrutinib vs Bendamustine/Rituximab in Treatment-Naive CLL or SLL

By: Jenna Carter, PhD
Posted: Tuesday, January 28, 2025

An article published in the Journal of Clinical Oncology presented data from the SEQUOIA clinical trial, with a median follow-up of 5 years in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) without del(17p). Mazyar Shadman, MD, MPH, of the Fred Hutchinson Cancer Center, University of Washington, Seattle, and colleagues compared the oral Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib with bendamustine plus rituximab (BR) in treatment-naive patients. At a median follow-up of 61.2 months, the investigators’ findings supported those of the initial phase III SEQUOIA study. Data also suggested zanubrutinib was a favorable treatment option for untreated patients with CLL and SLL.

“BTK inhibitors are a preferred treatment option for patients with CLL… and SLL.... However, longer-term exposure data for BTK inhibitors are more limited, and understanding these data is critical in establishing the role of BTK inhibitors in…treatment,” stated Dr. Shadman and colleagues.

A total of 479 patients without del(17p) were randomly assigned to receive oral zanubrutinib (n = 241) at 160 mg twice daily in 28-day cycles or BR (n = 238) intravenously for six cycles. Initial findings revealed better progression-free survival in patients who received zanubrutinib compared with BR at a median follow-up of 26.2 months and 43.7 months, respectively. The median progression-free survival was not reached for patients followed for a median of 61.2 months and treated with zanubrutinib; however, the median progression-free survival was 44.1 months in patients treated with BR (hazard ratio = 0.29; one-sided P = .0001). Additional findings revealed no new safety concerns.

“Whether ongoing studies using either a time-limited approach as BTK inhibitor monotherapy or combination therapy (eg, BTK inhibitor + BCL2 inhibitor) will improve upon or equal efficacy without the adverse event burden of continuous BTK inhibitor monotherapy remains unclear,” the authors concluded.

Disclosure: For full disclosures of the study authors, visit coi.ascopubs.org.


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