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BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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  • The P-III head-to-head APSEN trial involves assessing Brukinsa (160 mg- PO- bid) vs ibrutinib (420 mg- PO- qd) in 652 patients with r/r CLL or SLL- until disease progression or unacceptable toxicity
  • The interim analysis of the trial met its 1EP & pre-specified 2EPs i.e superior ORR & lower risk of atrial fibrillation or flutter respectively. PFS showed an early trend favoring Brukinsa
  • BeiGene plans to consult with global regulatory authorities and present the data at an upcoming major medical conference. The ongoing study with pre-specified endpoints of ORR and PFS will be further evaluated at the planned final analysis expected in 2022

  Ref: Business Wire | Image: Yicai Global

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