BeiGene's Brukinsa Tops JNJ's Imbruvica In Overall Response Rate In Leukemia Study

BeiGene Ltd BGNE has announced results from the Phase 3 ALPINE trial of Brukinsa (zanubrutinib) in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Brukinsa demonstrated superiority versus Johnson & Johnson's JNJ Imbruvica (ibrutinib) in overall response rate (ORR)
Brukinsa met the primary endpoint of superiority over ibrutinib in ORR in the final response analysis, with a response rate of 80.4% versus 72.9%.
A total of 652 patients enrolled in the ALPINE trial were followed for a median of 24.2 months. The next planned analysis of ALPINE data will be the PFS final analysis.
Brukinsa was generally well tolerated, with safety results consistent with previous studies.
Prespecified safety analysis showed that atrial fibrillation or flutter continued to be lower in the Brukinsa arm versus ibrutinib (4.6% vs. 12%).
In February, BeiGene announced that the FDA and European Medicines Agency had accepted supplemental new drug applications for Brukinsa in CLL.
In the U.S., the Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022.
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