Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced updated clinical data from the frontline arm of the Phase 1 KOMET-007 trial evaluating Ziftomenib in combination with intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML).
The companies said the updated results have been selected for an oral presentation at the 2026 European Hematology Association Congress, scheduled to take place in Stockholm, Sweden, in June. The findings focus on patients with two genetically defined AML subtypes: NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) AML.
According to the companies, the dataset includes results from 99 patients treated with ziftomenib at a daily dose of 600 mg combined with the standard “7+3” chemotherapy regimen consisting of cytarabine and daunorubicin. Researchers described the study as one of the largest datasets reported so far examining a menin inhibitor used alongside intensive frontline chemotherapy in AML.
The updated analysis showed high response rates across both patient groups. Among patients with NPM1-mutant AML, the composite complete response rate reached 96%, with 47 of 49 patients responding to treatment. In patients with KMT2A-rearranged AML, the composite complete response rate was reported at 90%, with 45 of 50 patients achieving a response.
Researchers also reported strong measurable residual disease (MRD)-negative response rates, which are considered an important indicator of deep remission. Among responders, MRD negativity was achieved in 83% of patients with NPM1-mutant AML and 82% of those with KMT2A-rearranged AML.
The trial additionally demonstrated encouraging durability of response with extended follow-up periods. Median follow-up was 14.9 months for the NPM1-mutant group and 9.3 months for the KMT2A-rearranged group. Investigators noted that the median duration of composite complete response had not yet been reached in the NPM1-mutant cohort, while it was reported at 11.2 months in the KMT2A-rearranged cohort.
Safety findings from the study were described as manageable and consistent across both AML subtypes. The companies stated that no new safety signals were observed during longer-term treatment and that the overall safety profile remained aligned with expectations for the therapy combination.
Mollie Leoni, Chief Medical Officer of Kura Oncology, said the growing dataset and extended patient follow-up continue to support the potential of ziftomenib as a foundational treatment option in frontline AML. She added that the company is continuing to advance the therapy combination through an ongoing Phase 3 registrational development program.
In addition to the oral presentation of KOMET-007 results, abstracts related to both the KOMET-007 and KOMET-017 studies have also been accepted for poster presentation and online publication at the scientific meeting.
Acute myeloid leukemia is an aggressive blood cancer with limited treatment options for many genetically defined patient populations. Menin inhibitors such as ziftomenib are being investigated as targeted therapies aimed at disrupting cancer-driving genetic interactions in AML cells.