BeiGene to share new Brukinsa data at ASH Annual Meeting

BeiGene (BGNE) announced it will share new data across a range of B-cell malignancies and assets, including Bruton’s tyrosine kinase, or BTK, inhibitor Brukinsa, at the 66th ASH Annual Meeting and Exposition in San Diego, December 7-10. BeiGene has 21 abstracts accepted at ASH, with four selected for oral presentation. Five-year follow-up results from Cohort 1 of the Phase 3 SEQUOIA study showed sustained progression-free survival, or PFS, benefit with Brukinsa in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma, with no new safety signals observed. Results from the LTE study of patients with treatment-naive and R/R CLL also showed that treatment with Brukinsa as a single agent or as an investigational treatment in combination with obinutuzumab achieved high overall and complete response rates. With a median follow-up of up to 6.5 years, the responses were sustained, and no new safety signals were observed. Results from an LTE study of patients with Waldenstrom macroglobulinemia from the Phase 3 ASPEN study, with a median follow-up of up to 5.8 years, demonstrated that treatment with Brukinsa monotherapy remained durable and the safety/tolerability profile remained favorable. Data from a Phase 2 study showed patients with prior intolerance to acalabrutinib were able to safely and effectively switch to Brukinsa, with the majority of patients not experiencing recurrence of prior acalabrutinib-intolerance events while maintaining or deepening responses. First-in-human Phase 1/2 CaDAnCe-101 presentations highlighted generally manageable safety and promising efficacy results for BTK degrader, BGB-16673, in patients with R/R CLL/SLL, WM, and R/R indolent non-Hodgkin’s lymphoma. BGB-16673, which induces BTK degradation, is the first and most advanced asset from BeiGene’s chimeric degradation activation compound platform. Oral presentation of the BGB-11417-101 Phase 1 study demonstrated B-cell lymphoma 2 inhibitor sonrotoclax in combination with BRUKINSA continued to show promising efficacy and was generally well-tolerated in patients with treatment-naive CLL/SLL; this combination is being evaluated in the Phase 3 CELESTIAL-TNCLL study.