ASH 2023 | TAG-AZA-VEN in the treatment of patients with newly diagnosed CD123+ AML
Naveen Pemmaraju, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the outcomes of a Phase Ib trial (NCT03113643) examining the combination of tagraxofusp (TAG), a CD123-directed agent, with azacitidine (AZA) and venetoclax (VEN) for treating patients with acute myeloid leukemia (AML). The regimen demonstrated promising safety and efficacy results in the frontline setting, even for patients with higher-risk characteristics. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
So I’m very excited that our tagraxofusp or TAG abstract was able to be presented here at the ASH meeting.
Just as a reminder, TAG is the first and only at this time approved CD123-targeting agent that I, myself and my group led to FDA approval exactly five years ago to this month, so December 2018. And it really is only approved for one indication, which is that of BPDCN or blastic plasmacytoid dendritic cell neoplasm, ages two and older...
So I’m very excited that our tagraxofusp or TAG abstract was able to be presented here at the ASH meeting.
Just as a reminder, TAG is the first and only at this time approved CD123-targeting agent that I, myself and my group led to FDA approval exactly five years ago to this month, so December 2018. And it really is only approved for one indication, which is that of BPDCN or blastic plasmacytoid dendritic cell neoplasm, ages two and older. But because the drug affects the target of CD123, we hypothesize if it could work in other malignancies such as AML, which also can express the target CD123.
And so with my colleague Doctor Andy Lane at the Dana-Farber, he and I set out to investigate that hypothesis in a Phase IB early stage trial, not only with the tagraxofusp agent, but in combination with AZA, and then in a triplet with venetoclax. And in brief, what we found in a small group of patients is that there is activity and efficacy of this triplet combination in frontline patients with AML, and in particular, it included what we call high risk patients, so older, unfit for standard chemo, TP53 mutations and other high risk mutations.
And so the take home point is that we were able to deliver this two and then three drug combination. We did not have very many toxicities that were unexpected. And that this now sets us up for larger studies to further test this combination in patients with AML.
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Disclosures
Incyte: Consultancy, Membership on an entity’s Board of Directors or advisory committees; ClearView Healthcare Partners: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Novartis Pharmaceuticals: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; ImmunoGen: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; CTI BioPharma: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Blueprint: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; CancerNet: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Cimeio Therapeutics AG: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Aplastic Anemia & MDS International Foundation: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; ASH Committee on Communications: Other: Leadership; PharmaEssentia: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Physician Education Resource (PER): Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; CareDx: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; ASCO Cancer.Net Editorial Board: Other: Leadership; BMS: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; National Institute of Health/National Cancer Institute (NIH/NCI): Research Funding; Dan’s House of Hope: Membership on an entity’s Board of Directors or advisory committees; Pacylex: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Neopharm: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; EUSA Pharma: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Curio Science: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; PeerView Institute for Medical Education: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Patient Power: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; OncLive: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Dava Oncology: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Menarini Group: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Harborside Press: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Protagonist Therapeutics, Inc.: Consultancy, Membership on an entity’s Board of Directors or advisory committees; Stemline: Consultancy, Membership on an entity’s Board of Directors or advisory committees; United States Department of Defense (DOD): Research Funding; Karger Publishers: Other: Licenses; Medscape: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Magdalen Medical Publishing: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Intellisphere: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Imedex: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Astellas: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Aptitude Health: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; HemOnc Times/Oncology Times: Other: Uncompensated; Bristol Myers Squibb Pharmaceuticals: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau.
