ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line Acute Myeloid Leukemia
Current TAP Partner
Marseille, France, September 18, 2024 – ImCheck Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy. Based on encouraging results from the Phase 1 dose-escalation portion of the EVICTION study evaluating ICT01 monotherapy in relapsed/refractory hematological malignancies, ImCheck initiated in October 2023 a randomized dose-optimization cohort (NCT04243499), evaluating two doses of ICT01 in combination with azacitidine and venetoclax, the current standard of care for newly diagnosed patients with AML who are deemed unfit for induction chemotherapy.
As reported at ESMO 2023, the Phase 1 dose-escalation cohort in relapsed/refractory hematological cancers included 26 patients who failed all available treatment options, 24 of which had AML, one with diffuse large B-cell lymphoma and one with follicular lymphoma. No dose-limiting toxicities were revealed for ICT01 administered at doses ranging from 200 μg to 75 mg every 21 days. Based on encouraging safety, pharmacokinetic and pharmacodynamic data, a dose-optimizing and efficacy-estimating part was initiated for patients with newly diagnosed AML who are older or deemed unfit for standard chemotherapy, which has enrolled 29 patients to date.