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: Up to 6 Years of Follow-Up With the Long-Term Extension

Constantine S. Tam, MD, presents updated long-term efficacy and safety results for zanubrutinib from the phase 3 ALPINE study and its long-term extension (LTE1) in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. With up to 6 years of follow-up and a median follow-up of approximately 54–63 months, zanubrutinib continued to demonstrate durable clinical benefit. Median progression-free survival was not reached in the overall population, with COVID-19–adjusted median PFS of 60.3 months overall and 50.2 months in patients with del(17p), supporting sustained efficacy in this high-risk subgroup. Overall response rates remained high, with deepening responses observed over time, including conversions to complete response. Long-term safety findings were consistent with prior reports, with no new safety signals identified. Although infections, hypertension, and neutropenia were common, the prevalence of key adverse events of special interest remained stable or declined over time. Overall, these data confirm zanubrutinib as a durable and well-tolerated long-term treatment option in relapsed/refractory CLL/SLL.