BGB-3111-302 : A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects with Waldenstrom's Macroglobulinemia (WM)

Trial Identifiers

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• NCT03053440
• BGB-3111-302

Scientific Title

A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects with Waldenstrom's Macroglobulinemia (WM)

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenstrom's Macroglobulinemia. This open-label, randomized study will compare the efficacy and safety of the Bruton's Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in subjects with Waldenström's Macroglobulinemia who require therapy. Subjects will have baseline bone marrow samples assayed for sequencing of the MYD88 gene. Approximately 150 subjects with the MYD88 mutation will be enrolled onto Cohort 1 and randomized to receive 160 mg BGB-3111 PO BID (treatment Arm A) or to receive 420mg ibrutinib QD (treatment Arm B) until disease progression or unacceptable toxicity. Subjects with MYD88 wild type will be enrolled to Cohort 2 and will receive 160 mg BGB-3111 PO BID (treatment Arm C) until disease progression or unacceptable toxicity.