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.