All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your AML Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2024-09-20T03:38:19.000Z

U.S. FDA grants Fast Track designation to ICT01 for the treatment of newly diagnosed AML

Sep 20, 2024
Share:
Learning objective: After reading this article, learners will be able to cite a new clinical development in acute myeloid leukemia.

On September 18, 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to ICT01, a humanized anti-butyrophilin 3A monoclonal antibody, in combination with azacitidine and venetoclax, for the treatment of patients aged ≥75 years with newly diagnosed acute myeloid leukemia (AML) unfit for induction chemotherapy.1 The decision is based on the encouraging results from the phase I dose-escalation portion of the EVICTION trial (NCT04243499).1,2

The EVICTION trial

EVICTION is an ongoing open-label, dose-escalation, phase I/IIa trial evaluating ICT01 in patients with relapsed/refractory (R/R) hematological malignancies.1 Interim findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023.3 Overall, 26 patients with R/R hematological malignancies received ICT01 monotherapy (AML; n = 24, follicular lymphoma; n = 1, diffuse large B-cell lymphoma; n = 1), at doses ranging from 200 μg to 75 mg every 21 days. The key findings were as follows:3

  • No dose-limiting toxicities were reported.
  • Among 10 evaluable patients at Week 8, the primary endpoint of disease control rate was 30%.
  • The treatment safely induced γ9δ2 T-cell activation and migration from the blood within hours of administration, showing effective target engagement.

A dose-optimizing and efficacy-estimating portion has been initiated to evaluate two doses of ICT01 in combination with azacitidine and venetoclax in newly diagnosed patients with AML who are older or ineligible for standard chemotherapy. To date, 29 patients have been enrolled.1

  1. GlobeNewswire. ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukemia for patients unfit for induction chemotherapy treatment. https://www.globenewswire.com/en/news-release/2024/09/18/2948005/0/en/ImCheck-Receives-FDA-Fast-Track-Designation-for-ICT01-in-Combination-with-Azacitidine-and-Venetoclax-in-First-Line-Acute-Myeloid-Leukemia-for-Patients-Unfit-for-Induction-Chemother.html. Published Sep 18, 2024. Accessed Sep 19, 2024.
  2. ClinicalTrials.gov. First-in-human study of ICT01 in patients with advanced cancer (EVICTION). https://clinicaltrials.gov/study/NCT04243499?intr=NCT04243499&rank=1. Updated July 22, 2024. Accessed Sep 19, 2024.
  3. ImCheck Therapeutics. ImCheck to present new positive data on ICT01 monotherapy in hematological cancers at ESMO 2023. https://www.imchecktherapeutics.com/all-press-release/news/imcheck-to-present-new-positive-data-on-ict01-monotherapy-in-hematological-cancers-at-esmo-2023/. Published Oct 16, 2023. Accessed Sep 19, 2024.

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
7 votes - 37 days left ...

Newsletter

Subscribe to get the best content related to AML delivered to your inbox