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C.S. Tam et al.
AbbVie; AÖ received research funding from BeiGene; MT is an employee of the Charles University General Hospital, served as a consultant for Takeda, Bristol Myers Squibb, Incyte, AbbVie, Amgen, Roche, Gilead Sciences, Janssen, Celgene, MorphoSys, received honoraria from Janssen, Gilead Sciences, Takeda, Bristol Myers Squibb, Amgen, AbbVie, Roche, MorphoSys, and Incyte; AT served as a consultant for and received honoraria from Janssen-Cilag SpA, AstraZeneca, and AbbVie; JCP, SBK, and SF are employees of and have equity ownership in BeiGene USA; VR is an employee of, has a leadership role and equity ownership in, and received travel funding from BeiGene USA; AC is an employee of, has equity ownership in, and received travel funding from BeiGene USA; JH is an employee of, has a leadership role with, and has equity ownership in BeiGene USA; PH received research funding from AbbVie, Pharmacyclics, Janssen, Gilead, and Roche, received honoraria from AbbVie and Janssen, and served on advisory boards for Acerta, Janssen, and AbbVie; JRB served as a consultant for AbbVie, Acerta, AstraZeneca, BeiGene, Catapult Therapeutics, Dynamo Therapeutics, Genentech/Roche, Gilead, Juno/Celgene, Kite, Loxo, Novartis, Pfizer, Pharmacyclics, Sun, Sunesis, TG Therapeutics, Nextcea and Verastem, received research funding from Gilead, Loxo, Sun and Verastem, received honoraria from Janssen and Teva, and served on the data safety monitoring board for Morphosys and Invectys; PSG, LL and MT have nothing to disclose.
Contributions
Together with BeiGene authors (AC, SF, VR, and JH), CST, PH, TR, PG, BSK, and JRB were responsible for study design, and CST, JRB, JCP, SBK, AC, SF, VR, and JH contributed to data interpretation and analysis;all investigators and their respective research teams reviewed patient records and con- tributed to data collection; BeiGene authors (JCP, SBK, SF, VR, AC, and JH) confirmed assay validation and data accuracy and compiled data for summation and analysis; CST, JCP, SBK, SF, and VR contributed to the first draft of the manuscript; all authors further contributed to final manuscript writing; CST had final responsibility to submit for publication. All authors had full access to all of the data, carefully reviewed the manuscript, and approved the final version.
Acknowledgments
The authors thank the patients who participated in the study, their supporters, and the investigators and clinical research staff from the study centers. Medical writing and editorial assistance were provided, under the direction of the authors, by Bio Connections.
Funding
This work, including medical writing and editorial assistance, was supported by BeiGene USA, Inc. BeiGene was involved in the study design, compilation of data, and statistical analysis.
References
1. Fischer K, Cramer P, Busch R, et al. Bendamustine in combination with ritux- imab for previously untreated patients with chronic lymphocytic leukemia: a multicen- ter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012;30(26):3209-3216.
2. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;3 76(9747):1164-1174.
3. Kastenhuber ER, Lowe SW. Putting p53 in context. Cell. 2017;170(6):1062-1078.
4. Dohner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chron- ic lymphocytic leukemia. N Engl J Med. 2000;343(26):1910-1916.
5. Yu L, Kim HT, Kasar S, et al. Survival of del17p CLL depends on genomic complex- ity and somatic mutation. Clin Cancer Res. 2017;23(3):735-745.
6. Aitken MJL, Lee HJ, Post SM. Emerging treatment options for patients with p53- pathway-deficient CLL. Ther Adv Hematol. 2019;10:2040620719891356.
7. Brander D, Islam P, Barrientos JC. Tailored treatment strategies for chronic lymphocytic leukemia in a rapidly changing era. Am Soc Clin Oncol Educ Book. 2019;39:487-498.
8. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213-223.
9. Brown JR, Hillmen P, O'Brien S, et al. Extended follow-up and impact of high- risk prognostic factors from the phase 3 RESONATE study in patients with previ- ously treated CLL/SLL. Leukemia. 2018; 32(1):83-91.
10. O'Brien S, Jones JA, Coutre SE, et al. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia
with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016;17(10):1409-1418.
11. Calquence® [package insert]. Gaithersburg, MD: AstraZeneca; November 2019.
12. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinu- tuzumab versus chlorambucil and obinu- tuzmab for treatment-naive chronic lym- phocytic leukaemia (ELEVATE TN): a ran- domised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-1291.
13. Venclyxto® [summary of product charac- teristics]. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG; April 2020.
14. Zydelig® [summary of product characteris- tics]. County Cork, Ireland: Gilead Sciences, Inc.; April 2019.
15. Stilgenbauer S, Eichhorst B, Schetelig J, et al. Venetoclax for patients with chronic lymphocytic leukemia with 17p deletion: results from the full population of a phase II pivotal trial. J Clin Oncol. 2018;36(19): 1973-1980.
16.Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236.
17. Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014; 370(11):997-1007.
18. O'Brien SM, Lamanna N, Kipps TJ, et al. A phase 2 study of idelalisib plus rituximab in treatment-naive older patients with chronic lymphocytic leukemia. Blood. 2015; 126 (25):2686-2694.
19.Guo Y, Liu Y, Hu N, et al. Discovery of zanubrutinib (BGB-3111), a novel, potent, and selective covalent inhibitor of Bruton's tyrosine kinase. J Med Chem. 2019 62(17):7923-7940.
20. Tam CSL, Trotman J, Opat S, et al. Phase 1 study of selective BTK inhibitor zanubruti- nib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;
134(11):851-859.
21. Xu W, Yang S, Zhou K, et al. Treatment of
relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study. J Hematol Oncol. 2020;13(1):48.
22. Brukinsa® [package insert]. Beijing, China: BeiGene Co. Ltd.; November 2019.
23. Hallek M, Cheson BD, Catovsky D, et al. iwCLL Guidelines for diagnosis, indica- tions for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760.
24. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
25. Mu S, Tang Z, Novotny W, et al. Effect of rifampin and itraconazole on the pharma- cokinetics of zanubrutinib (a Bruton's tyro- sine kinase inhibitor) in Asian and non- Asian healthy subjects. Cancer Chemother Pharmacol. 2020;85(2):391-399.
26.Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guide- lines for reporting parallel group random- ized trials. Ann Int Med. 2010;152:726-732.
27. Cheson BD, Byrd JC, Rai KR, et al. Novel targeted agents and the need to refine clin- ical end points in chronic lymphocytic leukemia. J Clin Oncol. 2012;30(23):2820- 2822.
28. Barrington SF, Mikhaeel NG, Kostakoglu L, et al. Role of imaging in the staging and response assessment of lymphoma: con- sensus of the International Conference on Malignant Lymphomas Imaging Working Group. J Clin Oncol. 2014;32(27):3048- 3058.
29. Herman SE, Niemann CU, Farooqui M, et al. Ibrutinib-induced lymphocytosis in patients with chronic lymphocytic leukemia: correlative analyses from a phase II study. Leukemia. 2014;28(11):2188-2196.
30. Hock BD, McIntosh ND, McKenzie JL, et
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