Kura Oncology(US:KURA)2025-06-18 21:30Kura Oncology (KURA) EHA Virtual Investor Event Summary Company Overview - Company: Kura Oncology (KURA) - Event Date: June 18, 2025 - Focus: Update on ZIFTOMENED, an investigational Menin inhibitor for acute myeloid leukemia (AML) Key Points Industry Context - Acute Myeloid Leukemia (AML): - Approximately 22,000 new cases annually in the U.S. - Median age of diagnosis is 69 years, with most patients diagnosed above this age [9][10] - Current therapies have limited long-term success, especially for older patients, with a 5-year survival rate of 60% to 50% for favorable AML [11] ZIFTOMENED Overview - Investigational Drug: ZIFTOMENED is under FDA review for relapsed and refractory NPM1 mutant AML, with a PDUFA target action date of November 30, 2025 [5] - Partnership: Collaboration with Kewa Kirin to advance the drug's development and commercialization [5] Clinical Data and Trials - Phase 1 Study: - Focused on the combination of ZIFTOMENED with intensive chemotherapy (7+3) for newly diagnosed AML patients with specific mutations (NPM1 and KMT2A) [15][16] - 82 patients enrolled, with a median age of 56; 93% remained on study at the data cutoff [22][18] - Safety profile similar to standard chemotherapy, with common adverse events including febrile neutropenia [22][23] - Efficacy Results: - Composite complete remission (CR) rates: 93% for NPM1 mutated patients and 89% for KMT2A rearranged patients [24] - Measurable residual disease (MRD) negativity rates: 68% for NPM1 mutated and 83% for KMT2A rearranged patients [25][32] - Median duration of CR not reached for both patient groups, indicating promising long-term outcomes [25][27] Market Opportunity - Addressable Market: - Estimated at over $7 billion annually for AML treatment, based on the potential to treat approximately 10,000 patients with Menin inhibitors for 12-24 months [47] - High unmet medical need, with 70% of patients relapsing within three years post-CR [47] Future Directions - Clinical Trials: - Plans to initiate two Phase 3 trials (COMMENT 17) to evaluate ZIFTOMENED in combination with high-intensity chemotherapy and in the maintenance setting post-transplant [38][50] - Focus on achieving MRD negativity as a primary endpoint, which is crucial for improving overall survival [40] Additional Insights - Patient Management: - Discussion on the potential to reduce the need for stem cell transplants by achieving deeper remissions with Menin inhibitors [61][62] - Importance of MRD negativity in guiding treatment decisions and improving patient outcomes [40][62] Conclusion - Kura Oncology is positioned to make significant advancements in the treatment of AML with ZIFTOMENED, addressing a critical unmet need in the market and aiming for improved patient outcomes through innovative therapies and clinical strategies [49][50]