Kura Oncology Clinical Trials Suspended in November following patient death Testing of the drug for acute myeloid leukemia (AML) is now allowed to resume after the company reached an agreement with the FDA on measures to prevent specific complications.
Kula announced Release part of the reservation after the close on Thursday. The San Diego-based biotech may now resume screening patients for a Phase 1b study aimed at finding the right dose to test in Phase 2.
Kura’s drug KO-539 is being evaluated for the treatment of AML cases characterized by a KM2A gene rearrangement. Kura’s small molecule blocks a protein called menin, which plays a role in the progression of leukemia in patients whose cancers carry the gene’s signature.
The menin inhibitor drug class has a known risk of complications called differentiation syndrome, in which cytokines, a signaling protein, are rapidly released from leukemia cells affected by the drug. Symptoms of potentially life-threatening complications include fever, weight gain, breathing problems with blood or pus in the lungs, low blood pressure, and kidney failure. Because this complication is known, clinicians pay attention to it. When the partial clinical suspension was announced last November, Kura CEO Troy Wilson said a “small number of cases” of differentiation syndrome were observed in all patients treated with KO-539, which were treated with steroids.
Differentiation syndrome was considered a potential cause of reported patient deaths. However, Wilson said at the time that other factors could have contributed to the death. The patient had a complex case that did not respond to early fourth-line therapy. In addition, fluid was observed around the heart, a problem not usually associated with differentiation syndrome. The cause of death could not be determined because the patient’s family did not consent to an autopsy.
In announcing the lifting of the partial clinical hold, Wilson said activity to resume patient screening is underway, and he expects the Phase 1b study to determine the recommended dose for the Phase 2 test in the coming months. He added that KO-539 remains safe and well-tolerated in patients and has also shown clinical activity in patients currently participating in the study. Kura plans to provide clinical trial updates at future medical meetings.
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