BeiGene Touts Initial Brukinsa Efficacy, Safety Profile For Leukemia, Compared To Imbruvica

BeiGene Ltd BGNE revealed an interim analysis of the Phase 3 ALPINE trial evaluating Brukinsa (zanubrutinib) to Johnson & Johnson’s JNJ Imbruvica (ibrutinib) for relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
In the study, Brukinsa shrunk tumors in more patients than Imbruvica did while causing fewer incidents of a dangerous heart side effect.
Data were unveiled at the European Hematology Association virtual congress.
Brukinsa triggered an overall response in 78.3% of patients, significantly more than Imbruvica’s 62.5% after a median of 15 months of follow-up.
But when analyzed by an independent data review committee, the BeiGene drug’s efficacy edge narrowly missed the statistical significance bar, with the response rates at 76.3% and 64.4% for Brukinsa and Imbruvica, respectively.
At the one-year mark, 94.9% of Brukinsa patients were still alive without disease worsening, versus 84% of patients in the Imbruvica arm, translating into a preliminary risk reduction of 60%.
Brukinsa did demonstrate a clear safety edge in atrial fibrillation, with 2.5% of Brukinsa patients suffered atrial fibrillation, significantly lower than the 10.1% for the Imbruvica group.
7.8% of Brukinsa patients stopped treatment because of side effects, compared with 13% of the Imbruvica group.
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