Shots:

• The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg- bid- or 320 mg- qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation
• The 1EPs of the trial was VGPR rate in the overall ITT population as assessed by IRC. VGPR rate (28% vs 19%) based on the modified 6th IWWM-6 & (16% vs 7%) based on the IWWM-6 response criteria; response rate (78% vs 78%); event-free DoR (94% vs 88%) @12mos. The therapy demonstrated safety benefits with improved tolerability
• Brukinsa is a BTK inhibitor- currently being evaluated in a broad clinical program as a monothx. or in combination with other therapies to treat multiple B cell malignancies

| Ref: Businesswire | Image: BeiGene