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ASH 2021 | AML data at ASH 2021 and implications on clinical practice

Andrew Wei, MBBS, PhD, Alfred Hospital and Monash University, Melbourne, Australia, shares his thoughts on the key news in acute myeloid leukemia (AML) presented at the ASH 2021 annual congress. Prof. Wei highlights the Phase III AGILE trial (NCT02677922) of ivosidenib plus azacitidine versus placebo plus azacitidine in newly diagnosed IDH1-mutated AML and the Phase II/III LACEWING trial (NCT02752035) of gilteritinib plus azacitidine versus azacitidine alone for patients with newly diagnosed FLT3-mutated AML ineligible for intensive chemotherapy. Prof. Wei comments on the data presented and their clinical implications moving forward. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

Transcript (edited for clarity)

So at this year’s ASH, probably the key trials presented were firstly, the results of the AGILE trial. This was ivosidenib plus as azacitidine versus placebo plus as azacitidine for IDH1-mutant patients. The very positive results I think now establishes in my mind, the potential for ivosidenib to perhaps be the new standard of care in this patient population. I think the results were very impressive...

So at this year’s ASH, probably the key trials presented were firstly, the results of the AGILE trial. This was ivosidenib plus as azacitidine versus placebo plus as azacitidine for IDH1-mutant patients. The very positive results I think now establishes in my mind, the potential for ivosidenib to perhaps be the new standard of care in this patient population. I think the results were very impressive. The response rates were very high. The event-free and the overall survival were all in favor of the ivosidenib arm and I think the favorable tolerability profile of the regimen, I think makes it very attractive in first line therapy.

The second key finding again from a randomized study was the failure of gilteritinib to improve survival for patients older who had FLT3 mutation. This was a really surprising and perhaps unexpected result and I think there’ll be a lot of analysis as to why this was the case. However, it would seem as if Ven/AZA remains the reasonable first step for patients who are unfit for intensive chemotherapy with a FLT3 mutation and that gilteritinib remains the preferred agent for first salvage in patients that don’t respond to first line therapy.

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