Gilteritinib combination with induction and consolidation chemo in newly diagnosed AML

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Published: 11 Dec 2017
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Dr Keith Pratz - Johns Hopkins University, Baltimore, USA

Dr Pratz speaks with ecancer at the 2017 ASH annual meeting about data from a phase I study of gilteritinib in newly diagnosed FLT3mut AML patients.

Gilteritinib is already in phase III studies for relapsed/refractory AML patients. 

For more on gilteritinib, watch our interview with Dr Jessica Altman at EHA 2017

ecancer's filming has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

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We’ll be presenting the results of the phase I study incorporating gilteritinib into induction and consolidation chemotherapy for newly diagnosed patients with acute myeloid leukaemia. We’ll be showing the results, clinical results, the adverse events and some of the biologic correlatives as part of the presentation.

If we could start off with what’s standard of care in this situation and then what gilteritinib adds to the situation?

The standard of care for acute myeloid leukaemia patients involves chemotherapy given intravenously over a week. This therapy will incorporate an oral kinase inhibitor that specifically targets a mutated gene in acute myeloid leukaemia that confers a poor outcome and the hope would be that incorporation of this agent would improve response rates, the durability of those responses and be a tolerable regimen.

Let’s go beyond that, let’s talk numbers.

The presentation will show that we’ve had very high rates of response and patients with FLT3-ITD or TKD mutated AML, of the 21 assessable patients with those mutations we’ve had remissions develop in all of the patients. 19 of the 21 patients had complete remissions and full count recovery, the other two patients had complete remissions with incomplete count recovery which we think is a good sign that this combination is going to be very active in this group of patients. Adverse events as a part of the study were typical of those seen with conventional induction therapy and we are going to show that this incorporation of gilteritinib is associated with a very robust suppression of the target FLT3 at timepoints across the treatment which we think is an important feature of any targeted agent. Suppression of the target has been found to be associated with favourable outcomes in other studies.

I was just about to ask what are the planned duration endpoints.

The therapy, gilteritinib, is given for two week intervals during the induction and consolidation courses. Then it’s given as a maintenance consistently once patients are through consolidation. The durability of the effectiveness of this treatment is yet to be determined but we have taken twelve patients now to allogeneic transplant as part of the study and seven patients are continuing maintenance therapy after transplant with gilteritinib.

What are the plans for expansion or increasing recruitment?

We’re currently in a dose escalation to another higher level. Once we’ve established that that’s a safe level we will be expanding again, twenty more patients. At that point there will be a transition to a later phase study incorporating gilteritinib and establishing its efficacy at that point.