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Kura Oncology And Kyowa Kirin Report Encouraging Long-Term Results for Ziftomenib / 7+3 Combination In Newly Diagnosed AML
– 12-month OS rate 94% among NPM1-m AML patients and 71% among KMT2A-r AML patients in single-arm KOMET-007 trial – – 96% CRc in newly diagnosed NPM1-m AML; 90% CRc in newly diagnosed KMT2A-r AML – – High rates of MRD negativity among NPM1-m AML responders assessed by both local assays and central testing – – Median OS not reached in either NPM1-m or KMT2A-r population with median follow-up of 17.6 months and 11.0 months, respectively – – 12-month survival rate, remission rates, MRD negativity,
About this update from Kura Oncology, Inc.
– 12-month OS rate 94% among NPM1-m AML patients and 71% among KMT2A-r AML patients in single-arm KOMET-007 trial – – 96% CRc in newly diagnosed NPM1-m AML; 90% CRc in newly diagnosed KMT2A-r AML – – High rates of MRD negativity among NPM1-m AML responders assessed by both local assays and central testing – – Median OS not reached in either NPM1-m or KMT2A-r population with median follow-up of 17.6 months and 11.0 months, respectively – – 12-month survival rate, remission rates, MRD negativity, durability of CR and tolerability compare favorably to 7+3 precedents and strengthen confidence in ongoing KOMET-017 Phase 3 registrational study – – Kura to host a virtual investor event tomorrow, June 12, 2026, at 8:00 a.m. ET / 5:00 a.m. PT – SAN DIEGO and TOKYO, June 11, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced encouraging long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. These results will be presented at the European Hematology Association 2026 Congress. These data compare favorably to historical standard-of-care data with 7+3 alone: 1KOMET-007 (N=49) at 600 mg ziftomenib; MRD neg < 10-4; 2Lachowiez et al., Blood Adv. 2020; 4(7): 1311–1320; 3Hernández-Sánchez et al., Leukemia. 2026; 40(2): 418-428; 4Othus et al. Leukemia. 2019; 33(2):371-378; 5Othman et al., Blood. 2024; 144(7):714-728, including Supplemental Material; 6Recher et al., Leukemia. 2022; 36(4): 913-922. Overall Survival (OS) for NPM1-m Patient Subset in Single-Arm KOMET-007 Trial: Median OS Not Reached KOMZIFTI™ (ziftomenib) is approved by the U.S. Food and Drug Administration (FDA) as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The use of ziftomenib in combination with 7+3 is investigational and has not been approved by any health authority. “The updated results from the KOMET-007 trial provide important evidence supporting the safety and clinical activity of adding ziftomenib to intensive chemotherapy for patients with newly diagnosed NPM1-m and KMT2A-r AML,” said Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancie...
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