FDA Lifts Partial Hold On Kura Oncology's Early-Stage Leukemia Trial

The FDA has lifted the partial clinical hold on Kura Oncology Inc KURA KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). 

• The partial clinical hold was lifted following an agreement with the agency on the company's mitigation strategy for differentiation syndrome, an adverse event related to differentiating agents in the treatment of AML.
• Related: See Why FDA Hit Red Light On Kura's Early-Stage Leukemia Trial.
• "Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the Phase 1b study and determining the recommended Phase 2 dose for KO-539 in the coming months," said Troy Wilson, President & CEO.
• The KOMET-001 is a Phase 1/2 trial to determine the safety, tolerability, and anti-tumor activity of KO-539 in patients with refractory or relapsed AML. 
• Related content: Benzinga's Full FDA Calendar.
• In Phase 1a dose-escalation portion of the trial, KO-539 demonstrated a wide therapeutic window with promising single-agent activity. 
• The Phase 1b portion includes two expansion cohorts – a lower dose of 200 mg and a higher 600 mg dose. 
• Kura expects to enroll 12 patients with NPM1-mutant or KMT2A-rearranged relapsed or refractory AML.
• Price Action: KURA shares closed 7.53% lower at $11.79 on Thursday.