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BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III (ALPINE) Trial for the Treatment of Chronic Lymphocytic Leukemia

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BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III (ALPINE) Trial for the Treatment of Chronic Lymphocytic Leukemia

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III (ALPINE) Trial for the Treatment of Chronic Lymphocytic Leukemia

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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