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Kura Oncology and Kyowa Kirin Report Combination Data for KOMZIFTI™ (Ziftomenib) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory AML
– 86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS –
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– 86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS – Median duration of complete response and overall survival not yet reached in newly diagnosed NPM1-m patients as of data cutoff – – 65% (31/48) ORR in R/R NPM1-m AML, 83% (19/23) ORR in venetoclax-naïve – – 41% (13/32) ORR in R/R KMT2A-r AML, 70% (7/10) ORR in venetoclax-naïve – – Triplet combination was well tolerated in both newly diagnosed and relapsed/refractory settings; addition of ziftomenib did not increase toxicity beyond that expected with venetoclax/azacitidine alone – – Ziftomenib’s broad clinical development program spans multiple front-line and relapsed/refractory regimens across NPM1-m, FLT3-m and KMT2A-r AML subtypes – – Company-sponsored registrational trials of ziftomenib in front-line AML are ongoing in both intensive chemotherapy-eligible and -ineligible patients – – Kura Oncology to host a virtual investor event today, December 8, 2025, at 12:30 p.m. ET / 9:30 a.m. PT – SAN DIEGO and TOKYO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced new data demonstrating a favorable safety profile and encouraging antileukemic activity for KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine (ven/aza) for the treatment of acute myeloid leukemia (AML) harboring NPM1 mutations (NPM1-m) or KMT2A rearrangements (KMT2A-r). The ongoing KOMET-007 Phase 1a/1b trial evaluated patients in cohorts with newly diagnosed chemotherapy-ineligible AML and relapsed/refractory (R/R) AML. The new data are being reported today in two oral presentations at the 67th Annual Meeting of the American Society of Hematology (ASH 2025). “The addition of ziftomenib to venetoclax and azacitidine has shown promising clinical activity, with 86% of newly diagnosed NPM1-mutated AML patients achieving composite complete remission and 68% attaining deep molecular MRD negativity, though median duration of response and overall survival remain immature,” said Gail J. Roboz, M.D., the William S. Paley Professor in Clinical Medicine and Director of the Clinical and Translational Leukemia Program at Weill Cornell Medicine and a hematologist/oncologist at NewYork-Presbyterian/Weill Cornell Medical Cen...