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FDA Places Clinical Hold on Kura Oncology's AML Trial

NEW YORK – Kura Oncology said on Wednesday that the US Food and Drug Administration has placed a partial clinical hold on the firm's Phase Ib trial of KO-539 for acute myeloid leukemia patients.  

The FDA initiated the clinical hold on the trial — dubbed KOMET-001 — after Kura reported that a patient had died while receiving KO-539 treatment. The firm believes that the patient's death may have been due to a life-threatening complication called differentiation syndrome.  

The treatment, KO-539, is a selective menin inhibitor that Kura is developing for relapsed or refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. In the KOMET-001 trial, the firm is evaluating the drug in two Phase Ib cohorts of patients with these specific biomarkers to determine the drug's optimal dose.  

Until Kura resolves the clinical hold, no new patients will be enrolled onto the trial. Patients already enrolled, meanwhile, may continue receiving KO-539. The firm is also holding off on issuing additional guidance with regard to the expected completed enrollment of the trial and the recommended Phase II dose.  

"Differentiation syndrome is known to be an on-target effect associated with therapeutic agents that induce differentiation, and we want to ensure physicians are fully informed and prepared to address these events if they occur," Kura's president and CEO Troy Wilson said in a statement. "Based on the totality of preclinical and clinical data, we continue to believe that KO-539 has the potential to address the significant unmet medical need of AML patients, including those with NPM1 mutations and KMT2A rearrangements."