On November 24, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (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 (Press release, Kura Oncology, NOV 24, 2021, View Source [SID1234596018]). The partial clinical hold was initiated following the Company’s recent report to the FDA of a Grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.
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Patients currently enrolled in the Phase 1b study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved. Kura is working closely with the FDA and the site investigators to resolve the partial clinical hold as quickly as possible.
"We share the FDA’s commitment to patient safety, and we appreciate our ongoing dialogue as we work diligently to address their questions," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "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. 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."
Until the partial clinical hold is resolved, and the Company has more clarity regarding the impact on timing, Kura is suspending guidance on the completion of enrollment in the KOMET-001 Phase 1b study and determination of the recommended Phase 2 dose of KO-539.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at 8:30 a.m. ET / 5:30 a.m. PT today, November 24, 2021. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 2452338. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.