ImCheck Therapeutics announced positive interim results from its Phase I/II EVICTION study of ICT01, a novel γ9δ2 T-cell activator, combined with azacitidine and venetoclax (Aza-Ven) in newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy. The combination therapy achieved a 96% composite complete remission rate and a 74% complete remission rate, showing promise even in patients with adverse- or intermediate-risk genetic mutations. Interim data also suggest a promising 83% overall survival rate at nine months for patients treated with 10 mg of ICT01.
This development is potentially transformative for AML treatment, especially for patients who cannot tolerate intensive chemotherapy. Current standard non-intensive regimens, like Aza-Ven, have high relapse rates and are not curative. ICT01’s ability to activate γ9δ2 T cells and enhance Aza-Ven’s efficacy may provide a much-needed new option, particularly for those with adverse genetic profiles who typically experience limited benefit from current treatments. The positive results in this difficult-to-treat population suggest a significant advancement in addressing the unmet need for effective AML therapies.
The study enrolled 45 patients aged 51 to 87, with 29 receiving 10 mg of ICT01 and 16 receiving 75 mg, both in combination with Aza-Ven. 39 patients were evaluable for efficacy. The 10 mg dose was identified as optimal for γ9δ2 T cell activation and downstream immune response, and will be the dose used in further clinical development. The combination therapy demonstrated a manageable safety profile, with most frequent adverse events being consistent with the known hematological toxicity of Aza-Ven.
These positive interim results pave the way for a randomized study and potentially accelerate the clinical development of ICT01. The findings suggest a potential shift in the treatment landscape for AML, offering new hope for patients who currently have limited options. Furthermore, the success of this approach could spur further research into harnessing γ9δ2 T cells for treating other cancers and diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
