30.01.2024 13:54:40
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Kura Oncology Reports Positive Preliminary Clinical Data From Phase 1 Trial Of Ziftomenib
(RTTNews) - Kura Oncology, Inc. (KURA) announced preliminary clinical data from the first 20 patients in KOMET-007, a Phase 1 dose-escalation trial of its menin inhibitor Ziftomenib, in combination with standard treatments for patients with specific types of acute myeloid leukemia or AML.
The continuous daily dosing of Ziftomenib at 200 mg QD for the initial 20 patients enrolled in KOMET-007 between July 2023 and November 2023, was well tolerated, with no reports of differentiation syndrome observed.
As of the data cutoff on January 11, 2024, all newly diagnosed patients treated with Ziftomenib and cytarabine/daunorubicin achieved a complete remission with full count recovery. At the data cutoff, 80% of patients remain on trial, including 100% of all NPM1-m patients.
The company stated that the 200 mg dose of Ziftomenib has been cleared in the R/R ven/aza cohorts, and enrollment at the 400 mg dose is ongoing. Troy Wilson, Chief Executive Officer of Kura Oncology, stated, "… Given that Ziftomenib targets foundational mutations at the core of up to 50% of AML cases, we are encouraged by its potential to transform treatment outcomes across the continuum of care. We expect to complete enrollment of all 85 patients in KOMET-001, our Phase 2 registration-directed trial of Ziftomenib in patients with R/R NPM1-m AML, by the middle of this year."
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