Deep molecular responses achievable in AML pts treated with gilteritinib

Patients who did not achieve a molecular response had a median overall survival of 28.4 weeks.

“As you could predict,” she added, “the molecular response was greater in those who attained a complete remission than those who had a CRp or Cri.”

Investigators observed similar results in patients who achieved an MMR, using the the cutoff point of 10^-3.

“When we stratified by MRD negative status,” she said, “which was an ITD signal ratio of 10^-4 or better, there’s clear separation of the Kaplan Meier curves for OS in this cohort again.”

Dr Altman pointed out that this was the first clinical trial to demonstrate that patients with AML treated with a FLT3 inhibitor can attain a molecular response.

“Also, and importantly, there is now a sensitive and specific assay for the detection of minimal residual disease in FLT3-ITD mutated patients and it has the potential to be widely adopted across trials and in clinical practice.”

MRD is prospectively being evaluated in 2 gilteritinib phase 3 maintenance studies.

The trial was sponsored by Astellas Pharma Global Development, Inc.