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Clinical Trial
. 2024 Nov 28;144(22):2360-2363.
doi: 10.1182/blood.2024025834.

A weekly low-dose regimen of decitabine and venetoclax is efficacious and less myelotoxic in a racially diverse cohort

Mendel Goldfinger  1 , Ioannis Mantzaris  1 , Aditi Shastri  1 , Yogen Saunthararajah  2 , Kira Gritsman  1 , R Alejandro Sica  1 , Noah Kornblum  1 , Nishi Shah  1 , David Levitz  1 , Bradley Rockwell  1 , Lauren C Shapiro  1 , Ridhi Gupta  1 , Kith Pradhan  3 , Xiaonan Xue  3 , Anne Munoz  1 , Aradhika Dhawan  1 , Karen Fehn  1 , Monica Comas  1 , Jhannine Alyssa Verceles  1 , Brian A Jonas  4 , Suman Kambhampati  5 , Yang Shi  6 , Ira Braunschweig  7 , Dennis L Cooper  1 , Marina Konopleva  1 , Eric J Feldman  1 , Amit Verma  1
Affiliations
Clinical Trial

A weekly low-dose regimen of decitabine and venetoclax is efficacious and less myelotoxic in a racially diverse cohort

Mendel Goldfinger et al. Blood. .

Abstract

A metronomic, low-dose schedule of decitabine and venetoclax was safe and effective in myeloid malignancies with few dose reductions or interruptions in an older diverse population. Median overall survival for patients with acute myeloid leukemia and a TP53-mutation was 16.1 and 11.3 months, respectively. This trial was registered at www.clinicaltrials.gov as #NCT05184842.

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Conflict of interest statement

Conflict-of-interest disclosure: A.S. received research funding from Kymera Therapeutics; advisory board fees from Gilead Sciences, Rigel Pharmaceuticals, and Kymera Therapeutics; consultancy fees from Janssen Pharmaceuticals; and honoraria from National Association of Continuing Education and PeerView. Y. Saunthararajah holds equity and board positions in EpiDestiny and Treebough Therapies and has patents: “Compositions comprising decitabine and tetrahydrouridine and uses thereof” (US-9259469-B2; US-9265785-B2; US-9895391-B2) and “Compositions containing decitabine, 5-azacitidine and tetrahydrouridine and uses thereof” (US-11376270-B2) and “Antitumor derivatives for differentiation therapy” (US-9926316-B2). K.G. receives research funding from iOnctura SA and ADC Therapeutics. B.A.J. is a consultant/advisor for AbbVie, Bristol Myers Squibb, Daiichi Sankyo, Gilead, GlycoMimetics, Kymera, Kura, Rigel, Schrodinger, Syndax, and Treadwell; is a member of the protocol steering committee for GlycoMimetics and the data monitoring committee for Gilead; and has received travel reimbursement/support from Rigel and research funding to his institution from AbbVie, Amgen, Aptose, Arog, Biomea Fusion, Bristol Myers Squibb, Celgene, F. Hoffmann-La Roche, Forma, Forty-Seven, Genentech/Roche, Gilead, GlycoMimetics, Hanmi, Immune-Onc, Jazz, Kymera, Loxo, Pfizer, Pharmacyclics, and Treadwell. M.K. has received research funding from AbbVie, Allogene, AstraZeneca, Genentech, Gilead, ImmunoGen, MEI Pharma, Precision, Rafael, Sanofi, Stemline; advisory/consulting fees for AbbVie, AstraZeneca, Auxenion, Bakx, Boehringer, Dark Blue Therapeutics, F. Hoffman La-Roche, Genentech, Gilead, Janssen, Legend, MEI Pharma, Redona, Sanofi, Sellas, Stemline, Vincerx; stock options or royalties from Reata Pharmaceutical (IP), Patent: Novartis, Eli Lilly, Reata Pharmaceutica. A.V. received research funding from Prelude, Bristol Myers Squibb, GlaxoSmithKline, Incyte, Medpacto, Curis, and Eli Lilly; is a scientific advisor for Stelexis, Novartis, Acceleron, and Celgene; receives honoraria from Stelexis and Janssen; and holds equity in Stelexis and Throws Exception. The remaining authors declare no competing financial interests.

References

    1. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383(7):617–629. - PubMed
    1. Bazinet A, Darbaniyan F, Jabbour E, et al. Azacitidine plus venetoclax in patients with high-risk myelodysplastic syndromes or chronic myelomonocytic leukaemia: phase 1 results of a single-centre, dose-escalation, dose-expansion, phase 1-2 study. Lancet Haematol. 2022;9(10):e756–e765. - PubMed
    1. Pratz KW, Jonas BA, Pullarkat V, et al. Long-term follow-up of VIALE-A: venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. Am J Hematol. 2024;99(4):615–624. - PubMed
    1. Saunthararajah Y, Sekeres M, Advani A, et al. Evaluation of noncytotoxic DNMT1-depleting therapy in patients with myelodysplastic syndromes. J Clin Invest. 2015;125(3):1043–1055. - PMC - PubMed
    1. Awada H, Mahfouz RZ, Kishtagari A, et al. Extended experience with a non-cytotoxic DNMT1-targeting regimen of decitabine to treat myeloid malignancies. Br J Haematol. 2020;188(6):924–929. - PMC - PubMed

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