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Kura Oncology And Kyowa Kirin Report Updated Clinical Data From KOMET-007, Phase 1a/1b Trial Of Ziftomenib, In Patients With Newly Diagnosed NPM1-M And KMT2A-R AML

Benzinga·06/12/2025 11:35:06
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– Encouraging clinical activity with deep responses demonstrated in the KOMET-007 trial with the combination of 600 mg ziftomenib with 7+3 in newly diagnosed patients with NPM1-m and KMT2A-r AML –

– 93% (41/44) and 89% (24/27) CRc observed in NPM1-m and KMT2A-r AML response-evaluable patients, respectively –

– 71% (24/34) and 88% (14/16) CR measurable residual disease (MRD)-negativity observed among responding NPM1-m and KMT2A-r AML patients, respectively –

– 96% (47/49) of NPM1-m and 88% (29/33) KMT2A-r AML patients remain alive and continue on-study –

– Combination was well tolerated with no additive myelosuppression –

– KOMET-017-IC (intensive chemotherapy) and NIC (non-intensive chemotherapy) randomized phase 3 studies (NCT07007312) expected to start in 2H 2025 –

– Kura Oncology to host virtual investor event to discuss results and broader ziftomenib development plan on June 18, 2025 at 4:30pm ET / 1:30pm PT –

SAN DIEGO and TOKYO, June 12, 2025 (GLOBE NEWSWIRE) --  Kura Oncology, Inc. (NASDAQ:KURA, "Kura"))) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") today provided positive updated clinical data from KOMET-007, a Phase 1a/1b trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care in patients with newly diagnosed NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data for the combination with cytarabine/daunorubicin (7+3) were presented as an oral presentation at the European Hematology Association 2025 Congress (EHA2025) being held in Milan, Italy from June 12-15, 2025.