Dual Regimen Shows Promise in Relapsed AML After HSCT

By Sarah Valentine - Last Updated: April 2, 2024

The combination of hypomethylating agents (HMA) and venetoclax is effective and well tolerated in patients with acute myeloid leukemia (AML) who relapsed after allogeneic hematopoietic stem cell transplantation (HSCT), according to a recent study.

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The retrospective analysis was led by Filip Ionescu, MD, of the University of South Florida, and published in Clinical Lymphoma, Myeloma and Leukemia. The study evaluated the rates of complete remission with or without hematological recovery (CR/CRi), measurable residual disease (MRD) negativity, CR/CRi duration, and overall survival (OS).

A total of 72 patients received an HMA and venetoclax in cycles at relapse following allogeneic HSCT. Of 67 patients with recorded results, 32 (48%) achieved CR/CRi. Mutations such as NPM1 or IDH 1 and IDH2 increased the likelihood of CR, while mutations such as TP53, which occurred in 15% of patients, were associated with lower rates of CR/CRi. Increasing time from allogeneic HSCT to relapse also improved the chances of CR/CRi.

Approximately one-third of patients experienced cytopenias, and most patients required reductions in venetoclax frequency due to delayed peripheral blood count recovery. Roughly 22% of patients experience neutropenic fever, and three patients ceased treatment due to gastrointestinal problems or grade 3 fatigue.

At a median follow-up of 24 months, 57 patients died. The median OS was “significantly longer” for patients who achieved CR/CRi compared with the entire cohort (19.7 months vs 5.5 months, respectively). In the entire cohort, the 12-month OS rate was 32% and the 24-month OS rate was 20%. Among CR/CRi patients, the 12-month OS rate was 61% and the 24-month OS rate was 42%.

“We found that HMA [plus venetoclax] is an active regimen in this high-risk, chemotherapy-refractory population, with response rates as high as 48%, which are similar to or higher than CR/CRi rates observed with intensive chemotherapy (30%-40%) or HMA alone (17%-23%),” wrote Dr. Ionescu and colleagues.

Reference

Ionescu F, David J, Ravichandran A, et al. Hypomethylating agents and venetoclax for acute myeloid leukemia relapsed after hematopoietic stem cell transplant. Clin Lymphoma Myeloma Leuk. 2024. doi:10.1016/j.clml.2024.02.005

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