Kura Oncology and Kyowa Kirin reported updated Phase 1 KOMET-007 data showing that ziftomenib plus standard 7+3 induction chemotherapy produced high composite complete response rates and deep MRD-negative responses in newly diagnosed NPM1-mutant or KMT2A-rearranged AML, with findings accepted for oral presentation at the 2026 EHA Congress.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Kura Oncology and Kyowa Kirin announced updated results from the frontline arm of the Phase 1 KOMET-007 trial (NCT05735184), evaluating ziftomenib, a selective menin inhibitor, in combination with standard 7+3 induction chemotherapy (cytarabine plus daunorubicin) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML).
The data, representing one of the largest reported datasets evaluating a menin inhibitor combined with intensive chemotherapy in frontline AML, have been accepted for an oral presentation at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden.
The analysis included 99 patients with newly diagnosed NPM1-m or KMT2A-r AML who received ziftomenib 600 mg once daily in combination with 7+3 chemotherapy. At the January 16, 2026 data cutoff, composite complete response (CRc) rates reached 96% (47/49) in patients with NPM1-m AML and 90% (45/50) in patients with KMT2A-r AML.
Deep molecular responses were also reported. Among patients achieving CRc, measurable residual disease (MRD)-negative status was observed in 83% (39/47) of patients with NPM1-m AML and 82% (32/39) of patients with KMT2A-r AML.
With extended follow-up, median follow-up duration reached 14.9 months in the NPM1-m cohort and 9.3 months in the KMT2A-r cohort. Median CRc duration was not reached in patients with NPM1-m AML and was 11.2 months in the KMT2A-r group.
The combination demonstrated a manageable and consistent safety profile across both molecular subtypes, with no new safety signals identified during longer-term treatment.
Additional analyses, including central MRD assessment, hematologic recovery, durability outcomes, and expanded safety findings, are expected to be presented at EHA 2026.
Mollie Leoni, MD, Chief Medical Officer of Kura Oncology, said the updated dataset continues to demonstrate high response rates, deep MRD negativity, and encouraging durability across genetically defined AML populations, supporting the ongoing Phase 3 registrational program evaluating ziftomenib-based frontline therapy.
The companies also announced that abstracts from the KOMET-007 and KOMET-017 programs were accepted for poster presentation and online publication at EHA 2026.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.