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Clinical Trial
. 2021 Feb 1;96(2):208-217.
doi: 10.1002/ajh.26039. Epub 2020 Nov 10.

Venetoclax with azacitidine or decitabine in patients with newly diagnosed acute myeloid leukemia: Long term follow-up from a phase 1b study

Daniel A Pollyea  1 , Keith Pratz  2 , Anthony Letai  3 , Brian A Jonas  4 , Andrew H Wei  5 , Vinod Pullarkat  6 , Marina Konopleva  7 , Michael J Thirman  8 , Martha Arellano  9 , Pamela S Becker  10   11 , Brenda Chyla  12 , Wan-Jen Hong  13 , Qi Jiang  12 , Jalaja Potluri  12 , Courtney D DiNardo  7
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Free article
Clinical Trial

Venetoclax with azacitidine or decitabine in patients with newly diagnosed acute myeloid leukemia: Long term follow-up from a phase 1b study

Daniel A Pollyea et al. Am J Hematol. .
Free article

Abstract

This analysis represents the longest-term follow-up for patients with acute myeloid leukemia (AML) treated with 400 mg of venetoclax plus azacitidine or decitabine. Adults with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in an open-label, non-randomized, multicenter phase 1b trial of venetoclax with azacitidine (AZA; 75 mg/m2 ; days 1-7) or decitabine (DEC; 20 mg/m2 ; days 1-5). Endpoints included safety, response rates (complete remission [CR], CR with incomplete blood count recovery [CRi]), response duration and overall survival (OS). The median follow-up time was 29 and 40 months for patients treated with venetoclax plus AZA and DEC combinations, respectively. Key Grade ≥ 3 AEs (AZA and DEC) were febrile neutropenia (39% and 65%), anemia (30% and 26%), thrombocytopenia (25% and 23%), and neutropenia (20% and 10%). The CR/CRi rate was 71% for venetoclax plus AZA and 74% for venetoclax plus DEC. The median duration of CR/CRi was 21.9 months and 15.0 months, and the median OS was 16.4 months and 16.2 months, for venetoclax plus AZA and DEC, respectively. These results support venetoclax plus hypomethylating agents as highly effective frontline AML therapies for patients unfit for intensive chemotherapy.

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References

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