FDA Places Clinical Hold on Kura Oncology’s Early-Stage Trial for AML Following Patient Death

Kura Oncology announced that the U.S. FDA has placed the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML) on a partial clinical hold. The partial clinical hold was initiated following the Company’s recent report to the FDA of a patient death potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.

While the cause of death is being investigated by the FDA, patients currently enrolled in the study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved.

KO-539 blocks the interaction of two proteins called menin and KMT2A/MLL that, together, allow for the survival, growth, and proliferation of certain kinds of leukemia cells. Preclinical data showed the potential anti-tumor activity of KO-539 in genetically defined subsets of acute leukemia, including those with rearrangements or partial tandem duplications in the KMT2A gene as well as those with oncogenic driver mutations in genes such as NPM1.

Differentiation syndrome (DS), also known as retinoic acid syndrome or all-tra...

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