FDA Places Partial Clinical Hold on Trial of Kura Oncology’s KO-539 in AML

The phase Ib KOMET-001 study evaluating Menin-KMT2A inhibitor KO-539 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) has been placed on partial clinical hold by the U.S. Food and Drug Administration (FDA). A recent report by Kura Oncology, KO-539’s manufacturer, of a grade 5 serious adverse event (AE) resulting in a patient’s death led to the agency’s pause.

The AE may be associated with differentiation syndrome, the manufacturer wrote in a press release. “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,” said Troy Wilson, PhD, JD, president and CEO of Kura Oncology.

Current study participants may continue to be treated with KO-539. However, the FDA has halted enrollment in the KOMET-001 study until the partial clinical hold is resolved.

Source: Kura Oncology press release, November 24, 2021.