Curis announces FDA removed partial hold on TakeAim Leukemia Phase 1/2 study

Curis announced that the U.S. Food and Drug Administration, FDA, has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose, RP2D, for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia or Myelodysplastic Syndromes. “We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received less than or equal to 2 prior lines of treatment). We also plan to initiate a front-line combination study of emavusertib with azacitidine and venetoclax. We believe emavusertib has the potential to be the cornerstone agent in the treatment of hematological malignancies.” said James Dentzer, President and Chief Executive Officer of Curis. “In 2024, we expect to have updated data from the TakeAim Leukemia monotherapy study, clarification of a monotherapy registrational study design, and initial data from an azacitidine and venetoclax combination study.”