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November 03, 2021
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VIDEO: Consider close monitoring after ceasing venetoclax-based therapy in AML

In this video, Alexander Edward Perl, MD, MS, spoke with Healio about a study assessing the potential benefit of ceasing venetoclax-based therapy after remission in patients with acute myeloid leukemia.

Perl, associate professor of medicine in the department of hematology at the Hospital of the University of Pennsylvania, noted that patients with AML who are being treated with venetoclax (Venclexta; Abbvie, Genentech) and a hypomethylating agent often ask whether they will require treatment indefinitely.

“We really haven’t had data on what the optimal duration of this regimen would be,” Perl said. “Yet we know in other settings we treat patients with AML for a defined period of time and then we observe.”

For the study, the researchers compared the natural history of patients with newly diagnosed AML who were treated with at least 12 months of venetoclax-based low-intensity therapy who were in first remission and then either electively ceased therapy and underwent ongoing monitoring (n = 14) or continued therapy until disease progression (n = 14).

Results showed durable treatment-free remissions among patients who stopped therapy, with a median treatment-free remission of 45.8 months. Of the 14 who stopped, seven relapsed.

Additionally, Perl noted that many patients who had durable responses had either NPM1, IDH1 or IDH2 mutations and that the best predictor of durable remission was whether patients achieved a measurable residual disease-negative state by flow cytometry-based measurable residual disease or molecular monitoring for NPM1 mutation with a quantitative highly sensitive assay.

Although the number of patients who had that amount of monitoring was small, the findings make “intuitive sense,” according to Perl.

“A prospective randomized discontinuation study is warranted based on these data, which support the idea of close monitoring of patients and then having an informed decision with your patient as to whether it makes sense to continue therapy as opposed to stop and observe,” Perl said.