BeiGene's Brukinsa Shows Superior Progression-Free Survival Versus JNJ's Treatment

BeiGene's Brukinsa Shows Superior Progression-Free Survival Versus JNJ's Treatment
  • BeiGene Limited BGNE announced topline data from the Phase 3 ALPINE trial of Brukinsa (zanubrutinib) against ibrutinib in previously treated patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Brukinsa achieved superior Progression-Free Survival (PFS) versus Johnson & Johnson's JNJ Imbruvica (ibrutinib) in a final analysis of the Phase 3 ALPINE trial.
  • Related: BeiGene's Brukinsa Tops JNJ's Imbruvica In Overall Response Rate In Leukemia Study.
  • Brukinsa was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports.
  • "With this final PFS analysis, BRUKINSA has achieved superior progression-free survival, as well as superiority in overall response rate versus ibrutinib," said Mehrdad Mobasher, Chief Medical Officer of Hematology at BeiGene. 
  • BeiGene's supplemental marketing application for Brukinsa for CLL or SLL is currently under review with the FDA, with a target action date of January 20, 2023.
  • Price Action: BGNE shares are up 4.21% at $130.79 on the last check Wednesday.
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