FDA Grants Fast Track Designation to ICT01 Plus Azacitidine and Venetoclax in AML

Acute myeloid leukemia (AML) cells: © LASZLO - stock.adobe.com

• The FDA has given fast track designation to ICT01 plus azacitidine and venetoclax (Venclexta) for the treatment of acute myeloid leukemia (AML) in patients 75 or older or those who have comorbidities that preclude standard induction chemotherapy.
• ICT01 is a humanized anti-butyrophilin (BTN) 3A monoclonal antibody.
• The phase 1/2a EVICTIONtrial (NCT04243499) is evaluating ICT01.

ICT01 plus azacitidine and venetoclax has earned FDA fast track designation for the treatment of patients with AML who are 75 years of age or older or cannot tolerate standard induction chemotherapy.¹

Fast track designation is intended to facilitate the development and review of agents that have the potential to treat serious conditions and fill unmet medical needs. With this designation, ImCheck Therapeutics, the sponsor, may be eligible for more frequent meetings with the FDA, priority review, and accelerated approval.

“The growing body of data on ICT01 together with the FDA’s fast track designation further validates our development of ICT01 in first-line patients [with AML] and highlights the critical need for therapies that generate higher response rates and improve overall survival for these patients,” said Stephan Braun, MD, PhD, chief medical officer of ImCheck Therapeutics, in a press release. “We are highly encouraged by ICT01’s potentially broad applicability in solid tumor and hematological cancer indications and look forward to sharing updates from the EVICTION study at upcoming scientific conferences.”

ICT01 is a humanized anti-BTN3A monoclonal antibody that selectively activates gamma-delta T cells and is being investigated in the phase 1/2a EVICTION study. Interim data from the phase 1 portion were presented at the 2023 ESMO Congress and showed a strong safety profile and promising clinical activity for ICT01. No dose-limiting toxicities were reported, and there was a 30% disease control rate (DCR) among the 10 evaluable patients at week 8.²

Following these findings, the randomized dose-optimization cohort evaluating ICT01 with azacitidine and venetoclax was initiated in October 2023.¹

The study’s primary end points are incidence of adverse events and DCR, and secondary end points include change in baseline in circulating gamma-delta T cells, pharmacokinetics, and objective response rate.³

The dose-optimizing portion of the study is looking at 2 dose levels of ICT01 in combination with azacitidine and venetoclax. Here, 29 patients with newly diagnosed AML have been enrolled to date.¹

REFERENCES:

1. 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. News release. ImCheck Therapeutics. September 18, 2024. Accessed September 18, 2024. https://tinyurl.com/yp6b488y

2. ImCheck to present new positive data on ICT01 monotherapy in hematological cancers at ESMO 2023. News release. ImCheck Therapeutics. October 16, 2023. Accessed September 18, 2024. https://tinyurl.com/562c8ub8

3. First-in-human study of ICT01 in patients with advanced cancer (EVICTION). ClinicalTrials.gov. Updated July 22, 2024. Accessed September 18, 2024. https://www.clinicaltrials.gov/study/NCT04243499