Kura Oncology ASH 2025 Update Summary Company Overview - **Company**: Kura Oncology (NasdaqGS: KURA) - **Event**: ASH 2025 update call - **Key Product**: Ziftomenib (branded as Comzifti) Industry Context - **Focus**: Acute Myeloid Leukemia (AML) treatment, specifically targeting NPM1 mutant and KMT2A rearranged AML - **Significance**: First ASH conference where ziftomenib is approved, highlighting its potential in AML treatment Core Points and Arguments 1. **Ziftomenib Approval**: Ziftomenib is now approved and available as 200 mg capsules, marking a significant milestone for Kura Oncology and its partners [4][5][6] 2. **Combination Therapy**: The combination of ziftomenib with azacitidine and venetoclax shows promising results in both newly diagnosed and relapsed/refractory AML settings [3][17] 3. **Efficacy Data**: - In newly diagnosed NPM1 mutant AML, the complete response (CR) rate was 73%, with an overall response rate of 89% [11][12] - In relapsed/refractory settings, CR rates were 27% for NPM1 mutant patients and 6% for KMT2A rearranged patients, with overall response rates of 66% and 41% respectively [22][26] 4. **Safety Profile**: The safety profile of ziftomenib in combination with azacitidine and venetoclax was favorable, with low rates of myelosuppression and adverse events such as differentiation syndrome and QTc prolongation [16][20][25] 5. **MRD Negativity**: The minimal residual disease (MRD) negativity rates were 68% at a threshold of 0.1% and 44% at 0.01% in newly diagnosed patients, indicating deepening responses over time [12][61] 6. **Clinical Development Plans**: Kura Oncology is committed to further developing ziftomenib in combination therapies and has a robust clinical development plan, including the ongoing COMET-017 trial [28][29] Additional Important Insights 1. **Patient Demographics**: The median age of patients in the studies was around 75 years, with a significant portion being older and unfit for intensive therapies [8][19] 2. **Long-term Treatment**: The combination therapy allows for prolonged treatment without significant dose reductions, which is crucial for maintaining response and preventing relapse [72][78] 3. **Comparative Efficacy**: The data suggests that ziftomenib may offer enhanced efficacy compared to other menin inhibitors, particularly in terms of MRD negativity and durability of response [40][61] 4. **Future Directions**: Kura Oncology aims to be the first approved menin inhibitor in the newly diagnosed setting, with ongoing trials designed to evaluate the effectiveness of ziftomenib in various patient populations [30][29] Conclusion Kura Oncology's ziftomenib demonstrates significant promise in treating AML, particularly in combination with established therapies. The favorable safety profile and high response rates position it as a potential leader in the evolving landscape of AML treatment. The company is focused on advancing its clinical trials to solidify its role in frontline therapy for AML patients.