BeiGene discloses new data in BRUKINSA, promising advancements pipeline at ASH

BeiGene (BGNE) “announced the presentation of new clinical data at the 66th American Society of Hematology Annual Meeting and Exposition, underscoring its leadership in chronic lymphocytic leukemia/small lymphocytic lymphoma through continued clinical success with BRUKINSA and promising advancements in its pipeline assets. Long-term follow-up results from the ongoing Phase 3 SEQUOIA study presented during ASH, which were simultaneously published in the Journal of Clinical Oncology, reaffirm BRUKINSA’s durable efficacy and differentiated safety profile across diverse CLL patient populations, including those with high-risk features. Additional findings spotlight the promising potential of BeiGene’s BTK-targeted chimeric degradation activation compound, BGB-16673, which has shown rapid and deep responses in B-cell malignancies in phase 1/2 clinical trials. BeiGene is also developing a next-generation BCL2 inhibitor, sonrotoclax, aiming to improve the safety profile and feasibility of use for this class of drugs and deliver deeper and more durable responses. Together, these advancements reflect BeiGene’s comprehensive approach to addressing the complexities of CLL and its commitment to reshaping the treatment landscape for B-cell malignancies. With a median follow-up of 61.2 months, data from the SEQUOIA study of patients with treatment-naive CLL/SLL demonstrated that treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab (BR). At 54 months, 80.1% of patients who received BRUKINSA remained progression-free while only 44.6% of patients who received BR remained progression-free. At 60 months, PFS rates were 75.8% and 40.1% for BRUKINSA and BR, respectively. Notably, for patients in the study with unmutated IGHV, a prognostic biomarker that indicates a patient’s CLL may be more aggressive, treatment with BRUKINSA reduced the risk of progression or death by 79% compared to BR. The safety profile of BRUKINSA was consistent with the results of prior studies, and no new safety signals were identified. Grade greater than or equal to3 treatment-emergent adverse events of interest with BRUKINSA and BR included infection, neutropenia, bleeding, thrombocytopenia, and anemia. Rates of atrial fibrillation were 7.1% with BRUKINSA and 3.5% with BR. The rate of discontinuation due to AEs was 20% in the BRUKINSA arm; 13% of patients discontinued BR early due AEs. In addition to BRUKINSA, BeiGene is advancing a robust pipeline to address the needs of CLL patients, including: Sonrotoclax (BCL2 Inhibitor): Presented data from the Phase 1/1b study demonstrated sonrotoclax, in combination with BRUKINSA, was generally well-tolerated and no cases of tumor lysis syndrome were reported in patients with treatment-naive CLL/SLL. BGB-16673 (BTK CDAC): Data from the Phase 1/2 CaDAnCe-101 CLL study demonstrated that treatment with BGB-16673 was generally well tolerated in this heavily pretreated population of patients.”