U.S. FDA suspends clinical trials of Kura's leukemia drug KO-539 due to death of 1 patient

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After a patient died due to a serious adverse event related to the mechanism of action of oral drugs, the U.

According to the announcement issued by Kura, the FDA has suspended the phase 1b trial of KOMET-001, which evaluates KO-539 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML)

KO-539 is a potent and selective menin inhibitor that is currently being developed for the treatment of AML, including AML patients with NPM1 mutations or KMT2A rearrangements

At present, patients who have been enrolled in the above-mentioned KOMET-001 phase 1b study can continue to receive KO-539 treatment, but they cannot be enrolled in other patients until part of the clinical suspension is lifted

DS is a known targeting effect associated with differentiation-inducing therapeutic drugs (differentiation inducers) in the treatment of AML

DS adverse events have been included in the black box warning of Tibsovo, an approved AML drug by Agios Pharmaceuticals, which was approved in July 2018

Kura’s management described the syndrome as “part of the drug’s mechanism of action,” and its leadership stated on a conference call discussing the news that the occurrence of the syndrome “should not surprise anyone.

Kura disclosed that the patient who died had previously experienced 4-line treatment failure and started to take a 200mg dose of the drug in the trial

Kura management stated that the FDA requires "three key pieces of information", including a safety database review, a description of the fatal syndrome mitigation plan, and reasons for the choice of 200mg and 600mg doses

Dr.

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