ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line Acute Myeloid Leukemia for Patients Unfit for Induction Chemotherapy Treatment.
Marseille, France, September 18, 2024, 11 am CET – 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 (European Society for Medical Oncology Congress 2023), 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.
“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. “We are highly encouraged by ICT01’s potentially broad applicability in solid tumor and hematological cancer indications and look forward to sharing updates from the EVICTION study at upcoming scientific conferences. To know more
