This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström’s Macroglobulinemia.
This open-label, randomized study compared the efficacy and safety of the Bruton’s Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in participants with Waldenström’s Macroglobulinemia who require therapy. Participants had baseline bone marrow samples assayed for sequencing of the MYD88 gene. 201 participants with the MYD88 mutation were enrolled and randomized to receive 160 mg BGB-3111 orally twice per day (PO BID) (treatment Arm A) or to receive 420mg ibrutinib orally once per day (PO QD) (treatment Arm B) until disease progression or unacceptable toxicity.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Cohort 1 |
R/R or TN (unsuitable for CIT) WM with MYD88 mutation |
Zanubrutinib |
Ibrutinib |
Primary Endpoints: CR/VGPR rate Secondary Endpoints: MRR (≥PR), PFS, DoR, symptom resolution, OS, safety |
Cohort 2 |
MYD88 WT WM |
Zanubrutinib |
None |
