As reported in the Journal of Clinical Oncology by Shadman et al, 5-year follow-up of the phase III SEQUOIA trial demonstrated that zanubrutinib continued to show a progression-free survival benefit over bendamustine plus rituximab in previously untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Study Details
In the open-label trial, 479 patients from sites in North America, Europe, and Asia/Pacific were randomly assigned to zanubrutinib (n = 241) or bendamustine plus rituximab (n = 238). The initial prespecified analysis at median follow-up of 26.2 months and subsequent analysis at a median of 43.7 months both found superior progression-free survival (primary endpoint) in the zanubrutinib group vs the bendamustine-plus-rituximab group. The current analysis was performed at a median follow-up of 61.2 months.
Key Findings
In the current analysis, median progression-free survival was not reached in the zanubrutinib group vs 44.1 months in bendamustine-plus-rituximab group (hazard ratio [HR] = 0.29, P = .0001). Estimated rates at 60 months were 76% vs 40%. Significantly prolonged progression-free survival in the zanubrutinib group vs the bendamustine plus rituximab group was observed among both patients with mutated IGHV genes (HR = 0.40, P = .0003) and those with unmutated IGHV genes (HR = 0.21, P < .0001).
Median overall survival was not reached in either the zanubrutinib group or the bendamustine-plus-rituximab group (HR = 0.89, P = .309). Estimated rates at 5 years were 85.8% vs 85.0%.
No new safety signals were detected.
The investigators concluded: “At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.”
Mazyar Shadman, MD, MPH, of Fred Hutchinson Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by BeiGene, USA, Inc. For full disclosures of the study authors, visit ascopubs.org.
