Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
Market
0.0%
Details
- Resolved Date
- 1/1/23
- Study Completion
- 1/9/26
- Company
- BeiGene
- Ticker
- ONC
- Type
- Trial Status
- Completed
- Trial Size
- 96
- Volume
- $0
- NCT
- NCT04116437
- Drug Description
- The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Yes. Trial-specific public readouts for NCT04116437 are clearly positive in tone: the Lancet Haematology publication says the results suggest zanubrutinib is a safe and viable option for BTKi-intolerant B-cell malignancies, and an updated sponsor poster says switching to zanubrutinib may provide clinical benefit.
Sources
Web Searchpubmed.ncbi.nlm.nih.gov1/1/23
Zanubrutinib in patients with previously treated B-cell malignancies intolerant of previous BTK inhibitors in the USA: a phase 2 study - PubMed
PubMed snippet for NCT04116437: “These results suggest that zanubrutinib, a safe and viable treatment… might fill that unmet need” for patients intolerant to ibrutinib or acalabrutinib.
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Sponsorbeigenemedical.com9/14/23
Updated Safety and Efficacy Results of Zanubrutinib in Patients With B-Cell Malignancies Who Are Intolerant of Ibrutinib and/or Acalabrutinib
Sponsor poster for BGB-3111-215/NCT04116437 says zanubrutinib was well tolerated; disease control was ≥95% in efficacy-evaluable patients; updated outcomes “suggest that… patients… can attain clinical benefit by switching to zanubrutinib.”
View source
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