European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

THE HAGUE, Netherlands, June 11, 2021 /PRNewswire/ -- Inhibition of B-cell receptor signaling via Bruton tyrosine kinase (BTK) has been a breakthrough for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib. The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials. The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.

Our interim analysis at 12 months after enrollment revealed that the overall response rate in zanubrutinib-treated patients was significantly higher than those treated with ibrutinib (78.3% vs 62.5%). Similarly, overall progression-free survival and overall survival rates were higher in the zanubrutinib group and zanubrutinib outperformed ibrutinib in several safety outcomes including rate of atrial fibrillation/flutter, major bleeding, adverse events leading to discontinuation, and grade ≥3 infection. However, zanubrutinib treatment increased the rate of neutropenia compared with ibrutinib (28.4% vs 21.7%). In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

The results of this study will be presented by Prof. Peter Hillmen in the Presidential Symposium on Friday, June 11.

Presenter: Professor Peter Hillmen

Affiliation: St James's University Hospital, Leeds, United Kingdom

Abstract:  #LB1900 FIRST INTERIM ANALYSIS OF ALPINE STUDY: RESULTS OF A PHASE 3 RANDOMIZED STUDY OF ZANUBRUTINIB VS IBRUTINIB IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA

About the EHA Annual Congress: Every year in June, EHA organizes its Annual Congress in a major European city. This year due to the persisting COVID19 pandemic, EHA organized a Virtual Congress for the second time. The Congress is aimed at health professionals working in or interested in the field of hematology. The scientific program topics range from stem cell physiology and development to leukemia; lymphoma; diagnosis and treatment; red blood cells; white blood cells and platelet disorders; hemophilia and myeloma; thrombosis and bleeding disorders; as well as transfusion and stem cell transplantation.

Website: www.ehaweb.org

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