Initiation of KOMET-008 Phase 1 Clinical Trial by Kura Oncology with Ziftomenib and Standard Care Combinations for Acute Myeloid Leukemia Patients with Specific Genetic Alterations
Overview
- Company: Kura Oncology, Inc.
- Indication: Acute Myeloid Leukemia (AML)
- Drug: Ziftomenib
- Trial Phase: Phase 1
- NCT ID: NCT06001788
Introduction
On February 26, 2024, Kura Oncology, Inc., a company at the forefront of precision oncology, announced the start of patient dosing in the KOMET-008 trial. This is the first Phase 1 study to explore the combination of ziftomenib, a menin pathway inhibitor, with standard care options including gilteritinib, FLAG-IDA, or LDAC.
Patient Population
The trial targets patients with relapsed or refractory acute myeloid leukemia, specifically those with NPM1 mutations or KMT2A rearrangements—genetic markers significant in AML pathogenesis. Approximately 30% of AML cases involve NPM1 mutations and another 5-10% involve KMT2A rearrangements. Patients with FLT3 co-mutations are also included due to their poor prognosis.
Trial Details
KOMET-008 is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of combining ziftomenib with standard treatments. The trial includes five dose escalation cohorts, with a special focus on patients with NPM1-mutant AML treated with the FLT3 inhibitor gilteritinib.
Previous Studies
Prior studies, such as the KOMET-007 trial, have evaluated the combination of ziftomenib with venetoclax and azacitidine as well as with standard induction chemotherapy. These studies have targeted both newly diagnosed and relapsed/refractory patient populations exhibiting relevant genetic alterations.
Regulatory Status and Preclinical Evidence
Ziftomenib has received orphan drug designation from the U.S. FDA and has shown potent anti-leukemic activity in preclinical studies.
Ongoing Research
Kura Oncology continues to explore the therapeutic potential of ziftomenib in combination with existing standards of care across various patient groups and treatment lines. The company's approach focuses on addressing unmet medical needs in genetically defined AML, evaluating potential synergistic effects from novel pharmacological combinations.