On December 7, 2025 ImCheck Therapeutics reported 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 (Free ASH Whitepaper) 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.

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The ASH (Free ASH Whitepaper) 2025 dataset builds on the promising efficacy signals previously shared at ASCO (Free ASCO Whitepaper) [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.

"ICT01 continues to demonstrate rapid and durable responses across AML subtypes. The updated ASH (Free ASH Whitepaper) 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."

Key Highlights:
Patient population: At the data cut-off on October 6, 2025, 57 patients aged 51 to 87 had been enrolled. Of these, 41 received 10 mg ICT01 and 16 received 75 mg ICT01, each in combination with Aza-Ven.
Rapid responses: More than 90% of patients treated with ICT01 (10 mg) achieved CRc4 as their best response already by end of Cycle 2.
Broad molecular activity: The 10 mg dose selected for future studies produced higher CR/CRc rates across molecular subtypes, including favorable-, intermediate-, and adverse-risk AML (e.g., TP53-mutated) versus the 75 mg dose.
Durability emerging: At a median follow-up of 10.8 months median DoR[5] was not yet reached for the 10 mg ICT01 dose.
Early survival signal: A 12-month OS[6] rate of 62% was observed, which is numerically higher than the ~54% reported for the Aza-Ven regimen in recent Phase 3 trials.
Favorable benefit–risk profile: Safety of the novel triplet regimen ICT01-Aza-Ven remains well manageable, with a 30-day mortality rate of 4%, and no deaths attributed to ICT01.
Regulatory momentum: ICT01 received Orphan Drug Designation from both FDA and EMA. The 10 mg ICT01 dose has been endorsed by FDA for further clinical development of the triplet regimen.
"ImCheck has in hand the alignment of strong clinical activity, a favorable safety profile, Orphan Drug Designations on both sides of the Atlantic, and now a clear regulatory-endorsed dose for ICT01 for accelerated late-stage development," added Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. "These results arrive at a transformative moment for ImCheck, following the announced acquisition agreement with Ipsen. We remain deeply grateful to the patients, investigators, and our team for bringing ICT01 to this important inflection point."

(Press release, ImCheck Therapeutics, DEC 7, 2025, View Source [SID1234661217])