Kura Oncology and Kyowa Kirin Report KOMZIFTI Data In AML, Showing High Remission Rates In Newly Diagnosed NPM1-m Patients, Strong Responses In Relapsed/Refractory NPM1-m And KMT2A-r AML, Favorable Safety Profile With Venetoclax/Azacitidine Triplet And Ongoing Registrational Trials Across Multiple Front-Line And R/R AML Subtypes

– 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).