Long-term results of patients receiving zanubrutinib in the phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL): Up to 6 years of follow-up with the long-term extension (LTE1)

ASH 2025 CLL/SLL Zanubrutinib Poster

Constantine S. Tam

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This report presents up to six years of follow-up for patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) treated with the BTK inhibitor zanubrutinib in the ALPINE study. Zanubrutinib continued to show durable benefits, with nearly half of patients remaining progression-free. Patients with high-risk genetic features (del(17p)) showed responses comparable to other patients in the study. Serious adverse events (AEs) were seen in 60% of patients, grade ≥3 AEs occurred in 79%, treatment-related grade ≥3 AEs in 42%, and 20% discontinued due to AEs. Fatal TEAEs occurred in 47 patients, most frequently due to infection. The safety profile remained consistent over time, with most side effects stable year-to-year. These long-term data support zanubrutinib as an effective treatment option for R/R CLL/SLL.

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