Kura, Kyowa Kirin to present updated frontline data from Phase 1 KOMET-007 trial

Kura Oncology, (KURA) and Kyowa Kirin (KYKOF) announced that updated results from the frontline arm of the Phase 1 KOMET-007 clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin in patients with newly diagnosed NPM1-mutant or KMT2A-rearranged acute myeloid leukemia have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association Congress in Stockholm, Sweden. The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML. As of the abstract data cut-off on January 16, 2026: High response rates across both molecular subtypes; Composite complete response rates of 96% for NPM1-m and 90% for KMT2A-r AML; Deep molecular responses; Measurable residual disease-negativity rates among CRc responders of 83% for NPM1-m and 82% for KMT2A-r AML; Encouraging durability with extended follow-up; Median follow-up of 14.9 months and 9.3 months; Median duration of CRc not reached and 11.2 months; Consistent and manageable safety profile; Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment; Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation. “With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets,” said Mollie Leoni, CMO. “These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program.”