Ziftomenib shows 94% survival rate in AML trial
Kura Oncology and Kyowa Kirin announced long-term results from the Phase 1/2 KOMET-007 trial, showing a 94% 12-month overall survival rate in NPM1-m AML patients treated with ziftomenib and chemotherapy. The trial reported high remission rates and deep molecular responses across both NPM1-m and KMT2A-r AML subtypes. The combination therapy demonstrated a consistent safety profile with no new safety signals.
*this image is generated using AI for illustrative purposes only.
Kura Oncology and Kyowa Kirin reported encouraging long-term results from the Phase 1/2 KOMET-007 trial evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. The data demonstrated a 12-month overall survival rate of 94% among NPM1-m AML patients and 71% among KMT2A-r AML patients. The companies announced that these results will be presented at the European Hematology Association 2026 Congress.
The trial results compare favorably to historical standard-of-care data with 7+3 alone. In the NPM1-m cohort, the composite complete remission rate was 96% with an objective response rate of 98%. The KMT2A-r cohort showed a 90% composite complete remission rate and a 92% objective response rate. Deep molecular responses were observed, with local CRc MRD-negativity rates of 85% in NPM1-m AML and 82% in KMT2A-r AML.
Key Efficacy Results
| Metric | NPM1-m AML | KMT2A-r AML |
|---|---|---|
| 12-month OS rate | 94% | 71% |
| Composite Complete Remission (CRc) | 96% | 90% |
| Objective Response Rate (ORR) | 98% | 92% |
| Local CRc MRD-negativity | 85% | 82% |
The durability of responses was encouraging, with median duration of complete response not reached for the NPM1-m AML cohort and 12 months for the KMT2A-r AML cohort. Median overall survival was not reached in either population at the time of data cut-off, following a median follow-up of 17.6 months for NPM1-m patients and 11.0 months for KMT2A-r patients.
Safety Profile
Ziftomenib 600 mg once-daily plus 7+3 was generally well tolerated, with no new or unexpected safety signals observed. The treatment showed low rates of ziftomenib-related cytopenias and minimal additive myelosuppression. There were no reports of Grade 4 differentiation syndrome or QTc prolongation events. A 60-day mortality rate of 2% was observed in NPM1-m patients.
"The updated results from the KOMET-007 trial provide important evidence supporting the safety and clinical activity of adding ziftomenib to intensive chemotherapy," said Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies at Yale Cancer Center and Professor of Medicine at Yale School of Medicine. He noted that the regimen could represent a transformative therapeutic approach and may allow some patients to avoid allogeneic hematopoietic cell transplantation.
Kura Oncology plans to host a virtual investor event on June 12, 2026, at 8:00 a.m. ET to discuss these findings. The companies plan to publish the data in a peer-reviewed publication in the second half of 2026.
What is the anticipated timeline for initiating a pivotal Phase 3 trial based on these encouraging Phase 1/2 results?
How will the companies differentiate ziftomenib's market position from other emerging targeted therapies for NPM1-m and KMT2A-r AML?
What specific regulatory pathways or designations, such as Breakthrough Therapy, will Kura and Kyowa Kirin pursue to accelerate the approval process?
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