Page 275 - Haematologica Vol. 109 - July 2024
P. 275

LETTER TO THE EDITOR
Acknowledgments
The authors wish to thank the study patients, their supporters, the investigators, and clinical research staff at the study centers. Assistance with medical writing and editorial support, under the direction of the authors, was provided by Lisa McGraw, PhD, and Elizabeth Hermans, PhD.
Funding
This study was sponsored by BeiGene, Ltd.
Data-sharing statement
BeiGene voluntarily shares anonymous data on completed studies responsibly and provides qualified scientific and medical researchers
References
1. Munir T, Brown JR, O’Brien S, et al. Final analysis from RESONATE: up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019;94(12):1353-1363.
2. Ghia P, Pluta A, Wach M, et al. Acalabrutinib versus investigator’s choice in relapsed/refractory chronic lymphocytic leukemia: final ASCEND trial results. Hemasphere. 2022;6(12):e801.
3. Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-859.
4. Hillmen P, Eichhorst B, Brown JR, et al. Zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma: interim analysis of a randomized phase III trial. J Clin Oncol. 2022;41(5):1035-1045.
5. Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388(4):319-332.
6. Shadman M, Flinn IW, Levy MY, et al. Zanubrutinib in patients with previously treated B-cell malignancies intolerant of previous Bruton tyrosine kinase inhibitors in the USA: a phase 2, open-label, single-arm study. Lancet Haematol. 2023;10(1):e35-e45.
access to anonymous data and supporting clinical trial documentation for clinical trials in dossiers for medicines and indications after submission and approval in the USA, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations. In addition, data can only be shared when it is feasible to do so without compromising the privacy of study participants. Qualified researchers may submit data requests/research proposals for BeiGene review and consideration through BeiGene’s clinical trial webpage at https://www.beigene.com/our-science-and-medicines/ our-clinical-trials/.
7. Predicine. PredicineHEME CLIA Validated NGS Assay for Hematologic Malignancies. https://www.predicine.com. Accessed July 2023.
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9. Nadeu F, Delgado J, Royo C, et al. Clinical impact of clonal and subclonal TP53, SF3B1, BIRC3, NOTCH1, and ATM mutations in chronic lymphocytic leukemia. Blood. 2016;127(17):2122-2130.
10. Bomben R, Rossi FM, Vit F, et al. Clinical impact of TP53 disruption in chronic lymphocytic leukemia patients treated with ibrutinib: a campus CLL study. Leukemia. 2023;37(4):914-918.
11. Del Poeta G, Biagi A, Laurenti L, et al. Impaired nodal shrinkage and apoptosis define the independent adverse outcome of NOTCH1 mutated patients under ibrutinib therapy in chronic lymphocytic leukaemia. Haematologica. 2021;106(9):2345-2353.
12. Nakhoda S, Vistarop A, Wang YL. Resistance to Bruton tyrosine kinase inhibition in chronic lymphocytic leukaemia and non- Hodgkin lymphoma. Br J Haematol. 2023;200(2):137-149.
13. Mohanty A, Sandoval N, Das M, et al. CCND1 mutations increase protein stability and promote ibrutinib resistance in mantle cell lymphoma. Oncotarget. 2016;7(45):73558-73572.
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