Advancement in Acute Myeloid Leukemia Treatment: Kura Oncology Initiates Phase 1 KOMET-008 Trial with Ziftomenib in Combination Therapies
Overview
Kura Oncology, Inc., a company leading the way in precision medicine for cancer, has begun a promising new clinical trial for Acute Myeloid Leukemia (AML) treatment.
Clinical Trial Details
- Company: Kura Oncology, Inc.
- Indication: Acute Myeloid Leukemia (AML)
- Drug: Ziftomenib
- Trial Phase: Phase 1
- NCT ID: NCT06001788
Study Objectives
The objective of the KOMET-008 trial is to assess the safety, tolerability, pharmacokinetics, and clinical efficacy of ziftomenib—a menin inhibitor used in a once-daily oral formulation. This drug is combined with other treatments to validate its synergistic potential.
Patient Cohorts and Treatment Plans
The study targets two AML patient cohorts:
- Those with NPM1 mutations.
- Those with KMT2A rearrangements.
Patients in the relapsed or refractory phases are under specific consideration. Treatment regimens involving ziftomenib include:
- Combination with gilteritinib
- Combination with FLAG-IDA
- Combination with LDAC
FDA Designation and Preclinical Data
Ziftomenib, having received Orphan Drug Designation by the FDA, interferes with the menin-KMT2A/MLL interaction, significantly implicated in AML pathogenesis. Preclinical studies have shown promising anti-leukemic activity.
Objectives and Future Trials
Kura Oncology aims to improve treatment for high-relapse and limited-survival AML cases, focusing on genetically specific AML subpopulations. In parallel with KOMET-008, ziftomenib is evaluated in the KOMET-007 trial for earlier treatment lines and wider patient services, reflecting the company's dedication to advancing cancer treatment.