- BeiGene Ltd (NASDAQ: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 (NYSE: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.
- Price Action: BGNE shares are down 5.37% at $186.02 during the market session on the last check Monday.
