The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia

Courtney D DiNardo¹, Keith W Pratz², Panayiotis Panayiotidis³, Xudong Wei⁴, Vladimir Vorobyev⁵, Árpád Illés⁶, Inho Kim⁷, Vladimir Ivanov⁸, Grace Ku⁹, Catherine L Miller¹⁰, Meng Zhang¹⁰, Fernando Tatsch¹⁰, Jalaja Potluri¹⁰, Xenia Schmidt¹⁰, Christian Récher¹¹

Affiliations

¹ Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
² Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
³ Haematology Clinic and BMT Unit, NKUA, Laiko General Hospital, Athens, Greece.
⁴ The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital, Zhengzhou, China.
⁵ Department of Hematology, S. P. Botkin City Clinical Hospital, Moscow, Russia.
⁶ Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
⁷ Seoul National University Hospital, Seoul, Republic of Korea.
⁸ Almazov National Medical Research Centre, Saint Petersburg, Russia.
⁹ Genentech, South San Francisco, California, USA.
¹⁰ AbbVie, Inc, North Chicago, Illinois, USA.
¹¹ Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse 3 Paul Sabatier, Toulouse, France.

PMID: 39487568
PMCID: PMC11625987
DOI: 10.1002/ajh.27515

The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia

Courtney D DiNardo et al. Am J Hematol. 2025 Jan.

. 2025 Jan;100(1):185-188.

doi: 10.1002/ajh.27515. Epub 2024 Nov 1.

Authors

Affiliations

¹ Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
² Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
³ Haematology Clinic and BMT Unit, NKUA, Laiko General Hospital, Athens, Greece.
⁴ The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital, Zhengzhou, China.
⁵ Department of Hematology, S. P. Botkin City Clinical Hospital, Moscow, Russia.
⁶ Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
⁷ Seoul National University Hospital, Seoul, Republic of Korea.
⁸ Almazov National Medical Research Centre, Saint Petersburg, Russia.
⁹ Genentech, South San Francisco, California, USA.
¹⁰ AbbVie, Inc, North Chicago, Illinois, USA.
¹¹ Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse 3 Paul Sabatier, Toulouse, France.

PMID: 39487568
PMCID: PMC11625987
DOI: 10.1002/ajh.27515

No abstract available

PubMed Disclaimer

Conflict of interest statement

C. D. DiNardo: Research support to institution from AbbVie, Agios, Astex, Beigene, Bristol Myers Squibb, Cleave, Foghorn, Forma/Rigel, ImmuneOnc, Loxo, Servier; consultancy/advisory role with AbbVie, Astellas, Bristol Myers Squibb, Genentech, GenMab, Gilead Sciences, GlaxoSmithKline, Immunogen, Jazz, Novartis, Notable Labs, Rigel, Servier; supported by the LLS Scholar in Clinical Research Award. K. W. Pratz: Research funding from AbbVie, Agios, Daiichi Sankyo, Millennium; advisory board member for AbbVie, Astellas, AstraZeneca, Boston Biomedical, Bristol Myers Squibb, Celgene, Novartis, Roche, Jazz Pharmaceuticals, and Servier. P. Panayiotidis: Grants/research support from AbbVie, Roche, Novartis, and Genesis and honoraria from AbbVie, Janssen, Roche, Novartis, Gilead, and Genesis. X. Wei: No conflicts of interest to disclose. V. Vorobyev: Advisor/consultancy for AbbVie, Janssen, Celgene, Novartis, Pfizer, Takeda, Roche, BeiGene, Amgen, and Sanofi. Á. Illés: Advisor/consultancy for AbbVie, Janssen, Celgene, Novartis, Pfizer, Takeda, Roche. I. Kim: Investigator in AbbVie‐sponsored clinical trials. V. Ivanov: Investigator in AbbVie‐sponsored clinical trials, Novartis, Astellas, MSD, Biocad, and Ascentage Pharma‐sponsored clinical trials; and educational events for AbbVie, Pfizer, Novartis, Roche, Biocad, and Sotex. G. Ku: Employment with Genentech, Inc. and may hold stock or other options. C. L. Miller, M. Zhang, F. Tatsch, J. Potluri, and X. Schmidt: Employment with AbbVie and may hold stock or other options. C. Récher: Consulting or advisory role with AbbVie, Amgen, Astellas, Bristol Myers Squibb, Boehringer, Daiichi‐Sankyo, Jazz Pharmaceuticals, Janssen, and Servier; research funding from AbbVie, Amgen, Astellas, Bristol Myers Squibb, Daiichi‐Sankyo, Iqvia, and Jazz Pharmaceuticals; and support for attending meetings and/or travel from AbbVie, Novartis, and Servier.

Figures

**FIGURE 1**
Duration of CR/CRi (A) and overall survival (B) by G‐CSF use post‐remission in patients achieving CR/CRi in VIALE‐A. Aza, azacitidine; CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; G‐CSF, granulocyte‐colony stimulating factor; Pbo, placebo; Ven, venetoclax.

See this image and copyright information in PMC

Cited by

Real-World Experience with Venetoclax Treatment for Newly-Diagnosed Acute Myeloid Leukemia in Japan (VENUS Study): An Interim Analysis Focusing on Neutropenia Management.
Goto T, Numata H, Katsuoka Y, Uoshima N, Hara S, Ando J, Ota S, Yoshimoto G, Matsuoka A, Hashiba H, Morita T, Tsutsui A, Imanaka R. Goto T, et al. Oncol Ther. 2025 Jun;13(2):519-527. doi: 10.1007/s40487-025-00329-3. Epub 2025 Mar 7. Oncol Ther. 2025. PMID: 40055300 Free PMC article.
Length of Washout Period After Remission Does Not Influence Relapse Risk in Patients with Acute Myeloid Leukemia Treated with Hypomethylating Agents Combined with Venetoclax.
Palumbo FE, Duminuco A, Longo L, Vitale DC, Maugeri C, Brancati S, Parisi MS, Palumbo GA, Romano GL, Drago F, Di Raimondo F, Gozzo L, Vetro C. Palumbo FE, et al. J Clin Med. 2025 Jul 15;14(14):5007. doi: 10.3390/jcm14145007. J Clin Med. 2025. PMID: 40725703 Free PMC article.
Newly diagnosed acute myeloid leukemia in unfit patients: 2026 treatment algorithms.
Gangat N, Dinardo CD. Gangat N, et al. Blood Cancer J. 2025 Aug 16;15(1):139. doi: 10.1038/s41408-025-01346-1. Blood Cancer J. 2025. PMID: 40818987 Free PMC article. Review.
Venetoclax schedule in AML: 7 vs 14 vs 21 vs 28 days.
Gangat N, Tefferi A. Gangat N, et al. Blood Cancer J. 2025 Apr 3;15(1):56. doi: 10.1038/s41408-025-01270-4. Blood Cancer J. 2025. PMID: 40180902 Free PMC article.

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. 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;99:615‐624. - PubMed
1. Wei AH, Panayiotidis P, Montesinos P, et al. Long‐term follow‐up of VIALE‐C in patients with untreated AML ineligible for intensive chemotherapy. Blood. 2022;140(25):2754‐2756. - PubMed
1. Dohner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345‐1377. - PubMed
1. Pratz KW, DiNardo CD, Selleslag D, et al. Postremission cytopenia management in patients with acute myeloid leukemia treated with venetoclax and azacitidine in VIALE‐A. Am J Hematol. 2022;97(11):E416‐E419. - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia

Affiliations

The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia

Authors

Affiliations

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

Grants and funding

LinkOut - more resources

Full Text Sources