Dr. Schadman on Zanubrutinib in CLL/SLL Intolerant to Prior BTK Inhibitors


Maziar Shadman, MD, MPH, physician, associate professor, Division of Medical Oncology, University of Washington School of Medicine, associate professor, Division of Clinical Research, Fred Hutchinson Cancer Center, discusses preliminary long-term findings from the evaluation of zanubrutinib (Brucinsa). In previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were intolerant to ibrutinib (Imbruvica) and/or acalabrutinib (Calquence).

At the 2023 iwCLL Annual Meeting, Schadman and colleagues presented follow-up data from a Phase 2 trial (NCT04116437), which evaluated zanubrutinib in patients with previously treated B-cell malignancies who were intolerant to other BTK inhibitors. Previously reported findings from this study showed that zanubrutinib achieved efficacy and was well tolerated in patients who discontinued ibrutinib and acalabrutinib due to their treatment-associated adverse effects (AEs), Shadman said. let start.

This updated analysis shows that most patients with CLL/SLL can receive treatment with zanubrutinib without experiencing recurrence of the AEs that prompted discontinuation of the prior BTK inhibitor, he says. Among patients with CLL/SLL who were intolerant to ibrutinib, 65 intolerance-related AEs did not recur during treatment with zanubrutinib, 22 recurred at a lower grade, and 8 recurred at the same grade. Among patients with CLL/SLL who were intolerant to acalabrutinib, 15 intolerance-related AEs did not recur with zanubrutinib, 2 recurred in a lower grade, and 4 recurred in the same grade.

Safety findings for zanubrutinib showed that treatment-emergent AEs (TEAEs) of any grade occurred in 93.4% of patients (n = 61), including 50.8% of patients who had grade 3 or higher TEAEs. The most common grade 3 or higher TEAEs were neutropenia (11.5%), COVID-19 (6.6%), and pneumonia (6.6%). TEAEs led to treatment discontinuation in 8.2% of patients, and 1 death due to TEAEs (COVID-19 pneumonia).

This study holds important practical implications, particularly for health care providers treating patients with CLL, as it may represent a treatment option for patients who benefit from BTK inhibitors but die due to AEs. Let’s face challenges, Shadman emphasizes. Long-term follow-up data from this study showed that in patients with CLL/SLL evaluable for efficacy (n = 57), zanubrutinib achieved an overall response rate of 71.9% (95% CI, 58.5%-83.0%) and The control rate when one disease occurred was 94.7% (95% CI, 85.4%–98.9%).

The findings of this study reinforce the notion that customizing treatments for individual patients is essential when making decisions for people with CLL, says Schadman. They concluded that these findings contribute to a growing body of evidence supporting personalized medicine approaches, underscoring the importance of ongoing clinical trials to refine and expand treatment options for those with CLL. do, which are intolerant to some BTK inhibitors.

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