BeiGene announced that the results of the final progression free survival (PFS) analysis of the ALPINE trial will be presented at a late-breaking oral presentation session at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans. ALPINE is a global Phase 3 trial comparing BRUKINSA (zanubrutinib)with IMBRUVICA® (ibrutinib) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). The results will be presented at 10:15 am CST during the late-breaking abstract session on Tuesday, December 13, 2022 in the Ernest N. Morial Convention Center, Hall E. In this final PFS analysis, BRUKINSA achieved superior PFS compared with ibrutinib, as assessed by both Independent Review Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p =0.0024, for both investigator and IRC).

The PFS results favored zanubrutinib consistently across major pre-defined subgroups including IGHV status and patients with del(17p)/TP53, regardless of IRC or investigator assessment. CLL is one of the most common types of leukemia, accounting for about one-quarter of new cases of leukemiai The condition is characterized by consecutive relapses, with response to therapy ultimately determining clinical benefit, including survival. At this pre-defined response analysis with a median follow up of 29.6 months, BRUKINSA was generally well-tolerated with a safety profile consistent with previous reports.

Overall discontinuation rates were lower with BRUKINSA (26.3%) compared to ibrutinib (41.2%), as well as discontinuations due to adverse events (16.2 vs 22.8%) or progressive disease (7.3 vs 12.9%). Cardiac safety measures at this analysis favored BRUKINSA compared with ibrutinib: the rate of atrial fibrillation/flutter in the BRUKINSA arm remained low (5.2%) compared with ibrutinib (13.3%) and there were zero grade 5 adverse events due to cardiac disorders with BRUKINSA versus six in the ibrutinib arm.