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Letters to the Editor
7Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany; 8Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA and 9Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA, USA
Correspondence:
WILLIAM BLUM - william.g.blum@emory.edu
doi:10.3324/haematol.2020.274118
Received: October 22, 2020.
Accepted: November 25, 2021.
Pre-published: December 2, 2021.
Disclosures: SV reports receiving funding from Boehringer Ingelheim for Advisory Board participation. JKA reports being part of an advisory council or committee for Astellas, Novartis, Cancer Expert Now, Agios, Glycomimetics, Theradex, AbbVie and Daiichi Sankyo, and being a speaker for PeerView, prIME Oncology, France Foundation. GLU reports receiving honoraria from Astellas and consulting fees from Genentech and Jazz. MST reports being part of an advisory council or committee for AbbVie, Daiichi-Sankyo, Orsenix, KAHR, Rigel, Delta Fly Pharma, Tetraphase, Oncolyze, Jazz Pharma, Roche, Biosight and Novartis, receiving grants or funds from AbbVie, Orsenix, ADC Therapeutics, Biosight, Glycomimetics, Rafael and Amgen, and other potential financial relationship with UpToDate. IG reports receiving grants or funds from Merck, Amgen, Amphivena, Celgene and Genentech. GL reports receiving funding of flow cytometry analysis of samples for this study from Boehringer Ingelheim. UB and AO report employment with Boehringer Ingelheim Pharma GmbH & Co. KG. PJ reports no conflict of interests. BR reports employment and other potential financial relationship with Boehringer Ingelheim Pharmaceuticals Inc. WB reports receiving consulting fees from Amerisource Bergen and grants or funds from Leukemia and Lymphoma Society, Xencor, Forma, Celyad and Novartis.
Contributions: JKA, GLU, MST, BR and WB designed the study; SV, WB, MT, JKA, MST, GLU and GL conducted the study, ana- lyzed data, wrote and edited the manuscript. All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work, which includes ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Acknowledgements: the authors would like to thank the patients and their families, the research staff and Anne Esler for statistical analysis. Medical writing assistance during the preparation of this manuscript was provided by Lynn Pritchard, Ashfield MedComms, an Ashfield Health Company, which was funded by Boehringer Ingelheim.
Funding: this work was supported by Boehringer Ingelheim.
Data sharing statement: the clinical study report (including appen- dices, but without line listings) and other clinical documents related to this study may be accessed on request. Prior to providing access, the documents and data will be examined, and, if necessary, redacted and de-identified to protect the personal data of study participants and per- sonnel, and to respect the boundaries of the informed consent of the
study participants. See https://trials.boehringer- ingelheim.com/data_sharing/sharing.html#accordion-1-2 for further details. Bona fide, qualified scientific and medical researchers may request access de-identified, analyzable patient-level study data, together with documentation describing the structure and content of the datasets. Researchers should use https://vivli.org/ to request access to raw data from this study.
References
1.Walter RB. Investigational CD33-targeted therapeutics for acute myeloid leukemia. Expert Opin Investig Drugs. 2018;27(4):339-348.
2. Williams BA, Law A, Hunyadkurti J, Desilets S, Leyton JV, Keating A. Antibody therapies for acute myeloid leukemia: unconjugated, toxin-conjugated, radio-conjugated and multivalent formats. J Clin Med. 2019;8(8):1261.
3. Feldman EJ, Brandwein J, Stone R, et al. Phase III randomized multi- center study of a humanized anti-CD33 monoclonal antibody, lin- tuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia. J Clin Oncol. 2005;23(18):4110-4116.
4. Borthakur G, Rosenblum MG, Talpaz M, et al. Phase 1 study of an anti-CD33 immunotoxin, humanized monoclonal antibody M195 conjugated to recombinant gelonin (HUM-195/rGEL), in patients with advanced myeloid malignancies. Haematologica. 2013;98 (2):217-221.
5. Sekeres MA, Lancet JE, Wood BL, et al. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013;98(1):119-128.
6. Feldman E, Kalaycio M, Weiner G, et al. Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 mon- oclonal antibody HuM195. Leukemia. 2003;17(2):314-318.
7. Castaigne S, Pautas C, Terre C, et al. Effect of gemtuzumab ozogam- icin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-1516.
8. Hills RK, Castaigne S, Appelbaum FR, et al. Addition of gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia: a meta-analysis of individual patient data from randomised controlled trials. Lancet Oncol. 2014;15(9):986-996.
9. Vasu S, He S, Cheney C, et al. Decitabine enhances anti-CD33 mon- oclonal antibody BI 836858-mediated natural killer ADCC against AML blasts. Blood. 2016;127(23):2879-2889.
10. Romain G, Senyukov V, Rey-Villamizar N, et al. Antibody Fc engi- neering improves frequency and promotes kinetic boosting of serial killing mediated by NK cells. Blood. 2014;124(22):3241-3249.
11. Stringaris K, Sekine T, Khoder A, et al. Leukemia-induced phenotypic and functional defects in natural killer cells predict failure to achieve remission in acute myeloid leukemia. Haematologica. 2014;99(5): 836-847.
12. Raza A, Jurcic JG, Roboz GJ, et al. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzum- ab: a phase 1 trial. Leuk Lymphoma. 2009;50(8):1336-1344.
13. Sutherland MK, Yu C, Lewis TS, et al. Anti-leukemic activity of lin- tuzumab (SGN-33) in preclinical models of acute myeloid leukemia. MAbs. 2009;1(5):481-490.
14. Kumai T, Oikawa K, Aoki N, Kimura S, Harabuchi Y, Kobayashi H. Assessment of the change in cetuximab-induced antibody-depen- dent cellular cytotoxicity activity of natural killer cells by steroid. Head Neck. 2016;38(3):410-416.
15. Eddy JL, Krukowski K, Janusek L, Mathews HL. Glucocorticoids reg- ulate natural killer cell function epigenetically. Cell Immunol. 2014;290(1):120-130.
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