Shots:

• The P-III trial (ALPINE) evaluating Brukinsa (160mg, BID) vs ibrutinib (420mg, qd) in 652 patients with r/r CLL or SLL across EU, the US, China, New Zealand & Australia
• The results showed a superior PFS for IRC & investigator in the final analysis, investigator-assessed PFS rates (78.4% vs 65.9%) @24mos., PFS benefits across all major subgroups, incl. high-risk del(17p)/TP53, higher ORR with a response rate (80.4% vs 72.9%)
• The therapy was well-tolerated, treatment discontinuation due to AEs (15.4% vs 22.2%), lower rate of cardiac disorders (21.3% vs 29.6%) & cardiac disorders leading to treatment discontinuation (0.3% vs 4.3%). The sNDA of Brukinsa is under the US FDA’s review for CLL with an anticipated PDUFA date on Jan 20, 2023

Ref: Businesswire | Image: BeiGene