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Outcomes in Patients with Poor-Risk Cytogenetics with or without TP53 Mutations Treated with Venetoclax and Azacitidine
Open accessPublished version of a preprint
Abstract
Purpose: To evaluate efficacy and safety of venetoclax + azacitidine in treatment-naïve patients with acute myeloid leukemia harboring poor-risk cytogenetics and TP53mut or TP53wt. Patients and Methods: We analyzed data from a phase III study (NCT02993523) comparing venetoclax (400 mg orally days 1–28) + azacitidine (75 mg/m2 days 1–7) or placebo + azacitidine, and from a phase Ib study (NCT02203773) of venetoclax + azacitidine. Patients were ineligible for intensive therapy. TP53 status was analyzed centrally; cytogenetic studies were performed locally. Results: Patients (n = 127) with poor-risk cytogenetics receiving venetoclax + azacitidine (TP53wt = 50; TP53mut = 54) were compared with patients with poor-risk cytogenetics (n = 56) receiving azacitidine alone (TP53wt = 22; TP53mut = 18). For poor-risk cytogenetics + TP53wt patients, venetoclax + azacitidine versus azacitidine alone resulted in composite remission rates (CRc) of 70% versus 23%, median duration of remission (DoR) of 18.4 versus 8.5 months, and median overall survival (OS) of 23.4 versus 11.3 months, respectively. Outcomes with venetoclax + azacitidine were comparable with similarly treated patients with intermediate-risk cytogenetics and TP53wt. For poor-risk cytogenetics + TP53mut patients, venetoclax + azacitidine versus azacitidine alone resulted in CRc of 41% versus 17%, median DoR of 6.5 versus 6.7 months, and median OS of 5.2 versus 4.9 months, respectively. For poor-risk cytogenetics + TP53mut patients, predominant grade ≥3 adverse events (AE) for venetoclax + azacitidine versus azacitidine were febrile neutropenia (55%/39%), thrombocytopenia (28%/28%), neutropenia (26%/17%), anemia (13%/6%), and pneumonia (28%/33%). AEs were comparable between TP53mut and TP53wt patients. Conclusions: In poor-risk cytogenetics + TP53mut patients, venetoclax + azacitidine improved remission rates but not DoR or OS compared with azacitidine alone. However, in poor-risk cytogenetics + TP53wt patients, venetoclax + azacitidine resulted in higher remission rates and longer DoR and OS than azacitidine alone, with outcomes comparable with similarly treated patients with intermediate-risk cytogenetics. Toxicities were similar in TP53mut and TP53wt patients. See related commentary by Green and Zeidner, p. 5235
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“Azacitidine (AZA) + venetoclax (VEN) is the standard of care for AML with a composite CR (CRc) rate in mTP53 AML of 55% (albeit CR rate of ~20%) but without improvement of OS (<6 months).”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with TP53 mutant MDS/AML (2025) · cites this paper as [19]
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“AZA + VEN has emerged as the standard of care for all subtypes of AML in older and unfit patients, but the combination remains controversial in mTP53 AML because even though the combination leads to a CRc rate of approximately 60%, the true CR rate was ~20% with no improvement of the median OS of approximately 6 months observed across multiple studies”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with TP53 mutant MDS/AML (2025) · cites this paper as [19]
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Metadata
- Authors
- Pollyea, D. A., Pratz, K. W., Wei, A. H., Pullarkat, V., Jonas, B. A., Recher, C., Babu, S., Schuh, A. C., Dail, M., Sun, Y., Potluri, J., Chyla, B., & DiNardo, C. D.
- Affiliations
- University of Colorado Anschutz (US)
- Abramson Cancer Center (US)
- The Royal Melbourne Hospital (AU)
- City Of Hope National Medical Center (US)
- University of California Davis Medical Center (US)
- 6Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
- 7Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana.
- Princess Margaret Cancer Centre (CA)
- 9Genentech Inc., South San Francisco, California.
- AbbVie (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- Corresponding author
- Pollyea, Daniel A.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2022-08-25
- Volume
- 28
- Issue
- 24
- Pages
- 5272-5279
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC9751752
- OpenAlex
- W4293253462
- Cited by
- 159
- References
- 29
- Citations by year
- 2026: 24 · 2025: 41 · 2024: 44 · 2023: 39 · 2022: 10
- FWCI
- 24.37
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Cancer Research (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Funders
- AbbVie (NCT02993523)
- Genentech (NCT02203773)
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Keywords
- venetoclax, azacitidine, acute myeloid leukemia, poor-risk cytogenetics, TP53 mutation, wild-type p53, combination therapy, remission duration, overall survival, febrile neutropenia, adverse events, treatment-naive patients, elderly patients, prognostic factors, prognostic score
- MeSH terms
- Antineoplastic Combined Chemotherapy Protocols, Azacitidine, Humans, Mutation, Sulfonamides, Leukemia, Myeloid, Acute, Tumor Suppressor Protein p53, Treatment Outcome, Clinical Trials, Phase I as Topic, Clinical Trials, Phase III as Topic, Bridged Bicyclo Compounds, Heterocyclic, Cytogenetic Analysis
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