Relapsed/refractory (R/R) FLT3-mutated (FLT3+) AML is typically resistant to venetoclax, and response durations are short when treated with single agent FLT3 inhibitors.

A multicentre study presented by Naval Daver, M.D., associate professor of Leukemia, included 54 patients with R/R FLT3+ AML who were treated with a combination of venetoclax and the FLT3 tyrosine kinase inhibitor, gilteritinib.

The combination therapy was safe and well-tolerated, other than frequent but manageable cytopenia that occurred in 80% of the trial participants, and it produced an encouraging composite complete response rate in 74.5% of the FLT3+ patients.

Additionally, the therapy cleared the FLT mutation in more than half (56.7%) of patients who responded to treatment, which may contribute to longer survival. 

This trial provides promising evidence that venetoclax and gilteritinib could be an effective and safe treatment option for patients with relapsed or refractory FLT3+ AML,” Daver said. “In the future, we plan to expand the trial to reach more patients, including developing frontline combinations of azacitidine with venetoclax and gilteritinib in older/unfit AML patients.”

Source: MD Anderson Cancer Center