BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III (ALPINE) Trial for the Treatment of Chronic Lymphocytic Leukemia
- The P-III (ALPINE) trial evaluates Brukinsa (60mg, PO, BID) vs ibrutinib (420mg, PO, qd) in 652 patients with r/r CLL or SLL
- The trial met the 1EPs i.e., the therapy showed superior ORR, response rate (80.4% vs 72.9%) with the median follow up (24.2mos.) & the results were consistent with interim analysis. In a prespecified safety analysis, the rate of AF or flutter @24.2mos. with median follow-up (4.6% vs 12.0%)., 13.0% vs 17.6% discontinued treatment due to AEs
- The company has submitted the results from the (ALPINE) trial to support MAA for Brukinsa in CLL in the US, EU & countries globally. The US FDA & EMA has accepted the Brukinsa’ sNDA for CLL with an anticipated PDUFA date of Oct 2022 in the US
Ref: Businesswire | Image: BeiGene
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