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A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia.
Future Oncol. 2018 Sep; 14(22):2229-2237.FO

Abstract

Waldenström macroglobulinemia (WM), an incurable B-cell malignancy, is sensitive to Bruton tyrosine kinase (BTK) inhibition with ibrutinib, a first-generation BTK inhibitor. Off-target effects of ibrutinib against TEC- and EGFR-family kinases are implicated in some adverse events. Patients with CXCR4WHIM and MYD88L265P mutations or who are MYD88WT have less sensitivity to ibrutinib than those with MYD88L265P and CXCR4WT disease. Zanubrutinib, a next-generation BTK inhibitor with potent preclinical activity in WM and minimal off-target effects, showed sustained BTK occupancy in peripheral blood mononuclear cells from patients with B-cell malignancies and promising responses in advanced WM. Described here is a head-to-head Phase III study comparing efficacy and safety of zanubrutinib and ibrutinib in WM patients. Effect of MYD88 and CXCR4 mutation status will be assessed.

Authors+Show Affiliations

Peter MacCallum Cancer Center, Melbourne, Victoria, Australia. University of Melbourne, Parkville, Victoria, Australia. St Vincent's Hospital, Fitzroy, Victoria, Australia. Royal Melbourne Hospital, Parkville, Victoria, Australia.UPMC GRC 11, Pitié Salpêtrière Hospital, Paris, France.BeiGene Company Ltd, San Mateo, CA 94403, USA.St James' University Hospital, Leeds, UK.Niguarda Cancer Center, Milan, Italy.BeiGene Company Ltd, San Mateo, CA 94403, USA.BeiGene Company Ltd, San Mateo, CA 94403, USA.BeiGene Company Ltd, San Mateo, CA 94403, USA.CCC Ulm, University Hospital Ulm, Ulm, Germany.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29869556

Citation

Tam, Constantine S., et al. "A Head-to-head Phase III Study Comparing Zanubrutinib Versus Ibrutinib in Patients With Waldenström Macroglobulinemia." Future Oncology (London, England), vol. 14, no. 22, 2018, pp. 2229-2237.
Tam CS, LeBlond V, Novotny W, et al. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. Future Oncol. 2018;14(22):2229-2237.
Tam, C. S., LeBlond, V., Novotny, W., Owen, R. G., Tedeschi, A., Atwal, S., Cohen, A., Huang, J., & Buske, C. (2018). A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. Future Oncology (London, England), 14(22), 2229-2237. https://doi.org/10.2217/fon-2018-0163
Tam CS, et al. A Head-to-head Phase III Study Comparing Zanubrutinib Versus Ibrutinib in Patients With Waldenström Macroglobulinemia. Future Oncol. 2018;14(22):2229-2237. PubMed PMID: 29869556.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. AU - Tam,Constantine S, AU - LeBlond,Veronique, AU - Novotny,William, AU - Owen,Roger G, AU - Tedeschi,Alessandra, AU - Atwal,Siminder, AU - Cohen,Aileen, AU - Huang,Jane, AU - Buske,Christian, Y1 - 2018/06/05/ PY - 2018/6/6/pubmed PY - 2019/1/1/medline PY - 2018/6/6/entrez KW - BTK inhibitor KW - Bruton tyrosine kinase KW - Waldenström macroglobulinemia KW - clinical trial KW - zanubrutinib SP - 2229 EP - 2237 JF - Future oncology (London, England) JO - Future Oncol VL - 14 IS - 22 N2 - Waldenström macroglobulinemia (WM), an incurable B-cell malignancy, is sensitive to Bruton tyrosine kinase (BTK) inhibition with ibrutinib, a first-generation BTK inhibitor. Off-target effects of ibrutinib against TEC- and EGFR-family kinases are implicated in some adverse events. Patients with CXCR4WHIM and MYD88L265P mutations or who are MYD88WT have less sensitivity to ibrutinib than those with MYD88L265P and CXCR4WT disease. Zanubrutinib, a next-generation BTK inhibitor with potent preclinical activity in WM and minimal off-target effects, showed sustained BTK occupancy in peripheral blood mononuclear cells from patients with B-cell malignancies and promising responses in advanced WM. Described here is a head-to-head Phase III study comparing efficacy and safety of zanubrutinib and ibrutinib in WM patients. Effect of MYD88 and CXCR4 mutation status will be assessed. SN - 1744-8301 UR - https://www.unboundmedicine.com/medline/citation/29869556/A_head_to_head_Phase_III_study_comparing_zanubrutinib_versus_ibrutinib_in_patients_with_Waldenström_macroglobulinemia_ L2 - http://www.futuremedicine.com/doi/full/10.2217/fon-2018-0163?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -