The propriety of upgrading responses to venetoclax + azacitidine in newly diagnosed patients with acute myeloid leukemia

Abstract

Widely-used response criteria, conditional upon count recovery, were developed for acute myeloid leukemia (AML) in the context of intensive chemotherapy (IC). Extending these definitions to continuously-administered venetoclax-based therapies might underestimate responses. Best practices for venetoclax-based therapies mandate interruption after an end-of-cycle 1 bone marrow biopsy shows morphologic remission with cytopenias. We analyzed 435 patients with newly-diagnosed AML and follow-up response assessments. Of the 101 who responded to venetoclax + azacitidine, overall survival for patients whose response was upgraded due to count recovery during a 14-day post-disease assessment period, from complete remission (CR) with incomplete recovery of blood counts to CR, was not different compared to patients who did not need the 14-day period for count recovery. These results were distinct from 138 IC patients. Although sample sizes for the comparison groups were small, and conclusions are exploratory and must be verified, these findings support consideration of new response criteria for venetoclax-based regimens.

Keywords:

• AML
• venetoclax
• upgrade
• ELN
• response

Acknowledgements

DAP is supported by the University of Colorado Department of Medicine Outstanding Early Career Scholars Program and the Leukemia and Lymphoma Society’s Scholar in Clinical Research award.

Disclosure statement

DAP serves as a consultant for Abbvie, Celgene/Bristol Myers Squibb, Genentech, Novartis, Karyopharm, Syndax, Takeda, Syros and Kiadis.