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

April 29, 2021 Auto Bot BeiGene, Clinical Trials, Trial 0

Shots:

  • 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

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