BeiGene, Ltd. (NASDAQ:BGNE) Files An 8-K

BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncological drugs for the treatment of cancer, today presented updated clinical data from an ongoing Phase I study of BTK inhibitor BGB-3111 in patients with Waldenström’s macroglobulinemia (WM) at the 9th International Workshop on Waldenström’s Macroglobulinemia and Symposium on Advances in Multiple Myeloma (IWWM-9) in Amsterdam, The Netherlands. The preliminary clinical data demonstrate that BGB-3111 is well-tolerated and highly active in WM, with an overall response rate of 92%, including major response in 83% and very good partial response (VGPR) in 33%, at a median follow-up time of 8.0 months.

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“The updated data continue to show that BGB-3111 is well-tolerated and highly active in Waldenström’s macroglobulinemia. The ability to achieve complete and sustained BTK inhibition in both circulating and nodal lymphocytes appears to have translated into very good response frequency and quality, as reflected by the VGPR rate of 33%,” commented Constantine Tam, MD, Disease Group Lead for Low Grade Lymphoma and Chronic Lymphocytic Leukemia at Peter MacCallum Cancer Centre, Australia, coordinating principal investigator of the study.


“We are very encouraged by the favorable safety profile and the frequency and depth of responses with BGB-3111 in Waldenström’s macroglobulinemia. The preliminary sequencing data suggest activity across WM genotypes, and are particularly encouraging for the very high VGPR rate observed amongst the most common WM genotype. We look forward to commencing a global Phase III study comparing BGB-3111 with ibrutinib in WM patients this year, as well as continuing broad development of BGB-3111 as a monotherapy and in combinations to treat a variety of B cell malignancies,” commented Jane Huang, MD, Chief Medical Officer, Hematology at BeiGene.

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