Benzinga -
- Kura Oncology Inc (NASDAQ: KURA) announced updated clinical data from the KOMET-001 Phase 1/2 trial of ziftomenib in patients with relapsed/refractory acute myeloid leukemia (AML).
- Ziftomenib demonstrated optimal clinical benefit at 600 mg with a 30% CR rate (6/20) in patients with NPM1-mutant AML, compared to 17% (1/6) at 200 mg.
- Notably, four NPM1-mutant patients who achieved a CR at 600 mg had IDH and/or FLT3 co-mutations.
- Related: Kura Oncology Reports Preliminary Proof Of Mechanism Data From Early-Stage In Head & Neck Cancer.
- Four of the seven patients with IDH co-mutations achieved a CR on ziftomenib. Three of the five patients assessed for MRD at 600 mg were MRD negative.
- The most common treatment-emergent adverse event observed was differentiation syndrome (DS).
- Kura believes the higher incidence is due to their much higher incidence of disease in extramedullary (outside of the bone marrow) sites, induced to differentiate by the high tissue penetrance demonstrated by ziftomenib preclinically.
- Combining ziftomenib with appropriate standards of care, the company believes it can reduce this extramedullary disease burden and consequent DS symptoms.
- Kura expects to dose the first patient in a registration-enabling Phase 2 trial in Q1 of 2023.
- Price Action: KURA shares are down 12.20% at $13.27 on the last check Monday.