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Venetoclax exposure reduced to 7 days vs standard exposure in patients with newly diagnosed AML

By Sari Cumming

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May 14, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in acute myeloid leukemia.


 

 

For patients with AML who are ineligible for intensive chemotherapy, the standard of care is a combination regimen of an HMA such as azacitidine (AZA), plus venetoclax (VEN).1 The effects of reduced VEN exposure to a 7-day cycle compared with the on-label 28-day cycle are unknown.1

A retrospective analysis compared response rates and tolerability of AZA for 7 days plus VEN for 7 days (7 + 7 regimen) from the first cycle (n = 82), vs standard-dose HMA plus VEN (std-HMA/VEN; n = 166), in patients with newly diagnosed AML.1 Findings from this analysis, including composite complete remission (CRc) rates and OS, were published by Willekens et al. in Blood Cancer Journal.1

 

Key learnings

The CRc rate was similar between cohorts (72% in each; p = 0.95). The median number of cycles until best response was two with the 7 + 7 regimen, vs one with std-HMA/VEN (p = 0.03).

The median OS was not significantly different between the cohorts, at 11.2 months (2-year OS, 28%) with the 7 + 7 regimen vs 10.3 months (2-year OS, 34%) with std-HMA/VEN (p = 0.75).

Platelet transfusion requirement during the first treatment cycle was significantly lower with the 7 + 7 regimen vs with std-HMA/VEN (62% vs 77%; p = 0.02); as was 8-week mortality (6% vs 16%; p = 0.03).

Similar response rates and OS were observed with reduced 7-day VEN cycles vs standard VEN exposure. Reduced VEN exposure may offer the potential for improved adherence and mitigation of drug interactions, particularly in older patients receiving multiple treatments.

Abbreviations: AML, acute myeloid leukemia; AZA, azacitidine; CRc, composite complete remission; HMA, hypomethylating agent; OS, overall survival; std, standard-dose; VEN, venetoclax.

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