Kura Oncology has dosed the first subjects in the open-label Phase Ia/Ib KOMET-015 trial, evaluating the oral investigational menin inhibitor ziftomenib, for advanced gastrointestinal stromal tumours (GIST) following imatinib failure.
This dose-escalation trial is structured to assess the tolerability, preliminary antitumour activity, and safety of ziftomenib in conjunction with imatinib in the adult population with this condition.
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Its primary goal is to assess the tolerability and safety and to establish the recommended Phase II dose, with expansion cohorts planned post-dose-escalation to further evaluate ziftomenib’s tolerability, clinical activity, and safety.
Key secondary endpoints focus on progression-free survival (PFS), clinical benefit, duration of response, overall survival (OS) and overall response rate (ORR).
GIST is said to be a widespread sarcoma form and is marked as a KIT-dependent solid tumour.
The therapy is being developed for treating genetically defined acute myeloid leukaemia (AML) and GIST individuals with high unmet medical needs.
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By GlobalDataKura Oncology chief medical officer Mollie Leoni said: “Building on compelling clinical activity of ziftomenib in patients with nucleophosmin 1 (NPM1)-mutant and lysine-specific methyltransferase 2A (KMT2A)-rearranged AML, we are committed to evaluating the full therapeutic potential of menin inhibitors for the treatment of cancer.
“Approximately 4,000 to 6,000 new cases of GIST are diagnosed each year in the US, and advanced GIST patients have limited treatment options.”
Based on data from the KOMET-001 trial, the US Food and Drug Administration (FDA) granted breakthrough designation for the therapy last year for relapsed/refractory (r/r) NPM1-mutant (NPM1-m) AML.
In November 2024, the company entered a worldwide strategic partnership with Kyowa Kirin focused on developing and commercialising ziftomenib for AML and other haematologic malignancies.
Enrolment in a Phase II registration-directed trial of the therapy in r/r NPM1-m AML has concluded.
In the second quarter of this year, both companies announced the submission of a new drug application to treat adults with r/r NPM1-m AML.
