ArticleHematological oncology2022
Venetoclax exposure-efficacy and exposure-safety relationships in patients with treatment-naïve acute myeloid leukemia who are ineligible for intensive chemotherapy.
Article in Hematological oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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Who cites it
31 citing papers in PubMed, 46 citations in OpenAlex.
- Pharmacological boosting of azacitidine/venetoclax in acute myeloid leukemia.Blood neoplasia · 2026Trial
- Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients.Investigational new drugs · 2024Trial
- Venetoclax plus azacitidine in Japanese patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy.Japanese journal of clinical oncology · 2022Trial
- Real-world pharmacokinetics of venetoclax in patients with acute myeloid leukemia in Japan.Blood neoplasia · 2026Article
- PK and PK/PD Modeling of Bcl2 Inhibitor S65487 in Patients With AML and Investigation of Nonlinearity With Microdosing.CPT: pharmacometrics & systems pharmacology · 2026Article
- Pharmacokinetics of venetoclax in a patient after whipple pancreaticoduodenectomy.Cancer chemotherapy and pharmacology · 2026Article
- Impact of venetoclax trough levels on safety and efficacy in the treatment of acute myeloid leukemia.Scientific reports · 2026Article
- Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting.Drug design, development and therapy · 2026Article
- Real-World Experience with Venetoclax Therapeutic Drug Monitoring in Acute Myeloid Leukemia: Role of Posaconazole, Correlation with Safety and Efficacy.Oncology research · 2026Article
- Real-World Pharmacokinetic and Exposure-Response Characterization of Venetoclax in Chinese Patients with Hematological Malignancies.Drug design, development and therapy · 2026Article
- Effect of Oral Posaconazole on Venetoclax Plasma Concentration and its Efficacy in Patients with Acute Myeloid Leukemia.Recent patents on anti-cancer drug discovery · 2026Article
- Predicting the toxicity-efficacy ratio of venetoclax in real-world patients.Annals of hematology · 2025Article
- Prognostic Role of Kidney Disease in Newly Diagnosed Acute Myeloid Leukemia Under Venetoclax-Based Low-Intensity Therapy.Cancers · 2025Article
- Safety and efficacy of semi-dose venetoclax plus azacitidine in unfit acute myeloid leukemia patients in China: a real-world single-center study.Investigational new drugs · 2025Article
- Exposure toxicity of venetoclax in acute myeloid leukemia patients in the real-life setting: impact of high exposure on delayed neutropenia.Haematologica · 2025Article
- Article
- Semi-mechanistic population PK/PD model to aid clinical understanding of myelodysplastic syndromes following treatment with Venetoclax and Azacitidine.CPT: pharmacometrics & systems pharmacology · 2025Article
- Exposure-response analyses of venetoclax combined with hypomethylating agents in myelodysplastic syndromes: a retrospective study.Frontiers in pharmacology · 2025Article
- The Anti-Leukemic Potential of Bee Venom.International journal of general medicine · 2025Review
- Venetoclax concentration affects the incidence of haematological adverse events in patients with acute myeloid leukaemia.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
12 authors at 5 institutions in 3 countries.
Funding
Abstract
This study evaluated venetoclax population pharmacokinetics (popPK) in patients with treatment-naïve acute myeloid leukemia and assessed the relationship between venetoclax exposure and clinical response for venetoclax in combination with either a hypomethylating agent (HMA) or low-dose cytarabine (LDAC). A total of 771 patients who received venetoclax from 5 Phase 1-3 studies were included in the popPK model. Exposure-response analyses included data from 575 patients for venetoclax/placebo plus HMA and 279 patients for venetoclax/placebo plus LDAC. The popPK model successfully characterized venetoclax plasma concentrations over time and confirmed venetoclax exposure did not vary significantly with age, weight, sex, mild to moderate hepatic impairment, or mild to severe renal impairment. Asian patients had 67% higher mean relative bioavailability than non-Asian patients, however the range of exposures in Asian patients was similar to non-Asian patients. For all efficacy endpoints with both treatment combinations, efficacy was higher in the venetoclax treatment groups compared with the respective control arm of placebo plus azacitidine or LDAC. Within patients who received venetoclax, no significant exposure-efficacy relationships were identified for either treatment combination, indicating that the beneficial effects of venetoclax were already maximized in the dose ranges studied. There was no apparent effect of venetoclax exposure on treatment-emergent Grade ≥3 thrombocytopenia or infections for either combination. Rates of treatment-emergent Grade ≥3 neutropenia were higher in the venetoclax treatment arms compared with the respective control arms; however, within patients who received venetoclax, there was only a shallow relationship or no apparent relationship with venetoclax exposure for venetoclax plus HMA or LDAC, respectively. Along with the efficacy and safety data previously published, the exposure-response analyses support the venetoclax dose regimens of 400 mg once daily (QD) plus HMA and 600 mg QD plus LDAC in treatment-naïve AML patients who are ineligible for intensive chemotherapy.
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