Source – Kura Oncology
Kura Oncology presented updated clinical data for its menin inhibitor, ziftomenib, at the 2023 European Hematology Association (EHA) Congress. The Phase I/II clinical trial, known as KOMET-001, demonstrated significant clinical activity of ziftomenib in heavily pretreated patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML).
Key findings from the data include a 35% complete remission (CR) rate among patients with NPM1-mutant AML treated at the recommended Phase 2 dose of 600 mg. Notably, patients with FLT3 or IDH co-mutations also achieved CR, with 33% and 50% response rates, respectively. The median duration of response for all NPM1-mutant patients was 8.2 months, indicating durable remissions. Importantly, the data suggested that ziftomenib is less likely to induce menin resistance mutations, a positive outcome for long-term treatment effectiveness.
“NPM1-mutant AML accounts for approximately 30% of AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists,” said Amir Fathi, M.D., Director of the Leukemia Program at the Massachusetts General Hospital. “The clinical data presented today continue to demonstrate the ability of ziftomenib to drive durable responses as a monotherapy in heavily pretreated patients with NPM1-mutant AML. In addition, data appears to suggest that ziftomenib is less likely to induce common MEN1 resistance mutations, coupled with emerging data showing the retention of activity against other key resistance mutants, are exciting, as we look to advance ziftomenib into combinations and treat patients in earlier lines of therapy.
The ongoing Phase II registration-directed trial for NPM1-mutant AML has shown better-than-expected enrollment. Kura Oncology is also preparing to initiate combination studies of ziftomenib with standard therapies in earlier lines of therapy and across various patient populations. The company’s focus on expanding the potential applications of ziftomenib underscores its commitment to transforming the standard of care for acute leukemias.
The positive clinical outcomes and potential best-in-class product profile of ziftomenib provide optimism for its future as a cornerstone therapy for AML treatment. Kura Oncology aims to leverage these promising results to accelerate the development and approval of ziftomenib, benefiting patients who currently face limited treatment options in their battle against AML.
