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Kura Oncology Presents Updated Clinical Data from KOMET-001 Trial of Menin Inhibitor Ziftomenib at American Society of Hematology Annual Meeting
– 30% CR rate at 600 mg in 20 patients with relapsed/refractory NPM1-mutant AML –– Low frequency of differentiation syndrome, including 5% rate (1/20) of ≥
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– 30% CR rate at 600 mg in 20 patients with relapsed/refractory NPM1-mutant AML –– Low frequency of differentiation syndrome, including 5% rate (1/20) of ≥ Grade 3 among NPM1-mutant patients treated at 600 mg –– 600 mg determined as recommended Phase 2 dose for ziftomenib in NPM1-mutant AML following positive Type C meeting with FDA –– Company expects to dose first patient in Phase 2 registration-directed trial in NPM1-mutant AML in first quarter of 2023 –– Further clinical development of KTM2A-rearranged AML to be pursued in combination with standards of care –– Multiple combination studies of ziftomenib in NPM1-mutant and KMT2A-rearranged AML anticipated in 2023 –– Management to host investor event today at 11:15 a.m. CT / 12:15 p.m. ET – SAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced updated clinical data from KOMET-001, a Phase 1/2 trial of the Company’s potent and selective menin inhibitor, ziftomenib, including an encouraging safety and tolerability profile and clinical activity in patients with relapsed/refractory acute myeloid leukemia (AML). These data are being featured during an oral session today at the American Society of Hematology (ASH) Annual Meeting. A copy of the presentation is available on Kura’s website at www.kuraoncology.com/pipeline/#publications. “NPM1-mutant and KMT2A-rearranged AML represent diseases of significant unmet need for which no approved targeted therapies exist,” said Harry Erba, M.D., Ph.D., Director of the Leukemia Program at the Duke Cancer Institute. “Notably, NPM1-mutant disease accounts for approximately 30% of new AML cases annually. Although typically associated with a more favorable prognosis, the risk of relapse remains high after initial chemotherapy for NPM1-mutant AML, especially when other poor risk mutations such as FLT3 are present as well. Relapsed/refractory NPM1 mutated AML is associated with a poor prognosis. These data reported today demonstrate encouraging activity and manageable toxicity of ziftomenib in heavily pretreated AML patients with NPM1 mutations.” In the Phase 1a dose-escalation trial, ziftomenib demonstrated a wide therapeutic window and encouraging monotherapy activity in an all-c...