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ImCheck Reports Durable Responses and Early Overall Survival Signal with ICT01 in First-line AML at ASH 2025

8 December 2025
News

Marseille, France, December 7, 2025, 5:30 pm ET/ 11:30 pm CET ImCheck Therapeutics today announced updated results from its Phase I/II EVICTION study evaluating ICT01, a first-in-class γ9δ2 T-cell activator, in combination with azacitidine and venetoclax in newly diagnosed AML patients ineligible for intensive chemotherapy. The data were presented by Dr. Sylvain Garciaz (Institut Paoli-Calmettes, Marseille, France) in an oral session at the 67th ASH Annual Meeting, taking place December 6-9, in Orlando, Florida. The data presentation follows ImCheck’s recently announced agreement to be acquired by Ipsen, pending transaction close.
The ASH 2025 dataset builds on the promising efficacy signals previously shared at ASCO [2] 2025, highlighting rapid, deep, and durable responses with a favorable safety profile and encouraging early overall survival. Notably, responses were strongest at the 10mg ICT01 dose, which has now been endorsed by the FDA for further development. In 2025, ICT01 also received Orphan Drug Designation from both the FDA[3] and EMA[4].
“ICT01 continues to demonstrate rapid and durable responses across AML subtypes. The updated ASH data further strengthens our confidence in ICT01’s ability, when added to Aza-Ven, to deliver deep, lasting remissions that have the potential to translate into meaningful overall survival improvement for patients” said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. “We see an early onset of complete remissions, consistently strong efficacy at the selected dose across molecular subtypes, and signs of durable responses even in adverse-risk patients. These findings together with the encouraging early survival signal create a compelling case as we advance toward late-stage development.”

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