The FDA has granted Fast Track designation to ICT01, in combination with azacitidine and venetoclax, for the treatment of acute myeloid leukemia (AML) in patients 75 years or older, or those with comorbidities preventing standard induction chemotherapy. This decision aims to expedite the development and review of this therapeutic approach for a serious condition with unmet medical needs.
ICT01: Targeting Gamma-Delta T Cells in AML
ICT01 is a humanized anti-BTN3A monoclonal antibody designed to selectively activate gamma-delta T cells. It is currently being investigated in the phase 1/2a EVICTION trial (NCT04243499), an open-label, multicohort study evaluating ICT01 as both a monotherapy and in combination with other agents in solid and hematological tumors.
EVICTION Trial: Evaluating Safety and Efficacy
Interim data from the phase 1 portion of the EVICTION trial, presented at the 2023 ESMO Congress, demonstrated a strong safety profile for ICT01. The data, which included patients with relapsed/refractory hematologic malignancies, showed no dose-limiting toxicities across ICT01 doses ranging from 200 μg to 75 mg every 21 days. Furthermore, a disease control rate (DCR) of 30% was observed among the 10 evaluable patients at week 8.
Following these encouraging findings, a randomized dose-optimization cohort was initiated in October 2023 to evaluate two dose levels of ICT01 in combination with azacitidine and venetoclax. To date, 29 patients with newly diagnosed AML have been enrolled in this dose-optimizing portion of the study.
The primary endpoints of the EVICTION trial include the incidence of adverse events and DCR. Secondary endpoints encompass changes in circulating gamma-delta T cells, pharmacokinetics, and objective response rate.
Clinical Significance and Future Directions
"The growing body of data on ICT01 together with the FDA’s fast track designation further validates our development of ICT01 in first-line AML patients 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. He also noted ICT01's potentially broad applicability in both solid tumor and hematological cancer indications.
The Fast Track designation offers ImCheck Therapeutics the opportunity for more frequent meetings with the FDA, priority review, and potential accelerated approval. This regulatory pathway is designed to bring promising therapies to patients sooner, addressing critical unmet needs in the treatment of AML.
