Kura Oncology Ziftomenib Shows 90-96% CRc in AML Trial
Kura Oncology and Kyowa Kirin announced updated positive results from the Phase 1 KOMET-007 trial of ziftomenib in combination with 7+3 chemotherapy for newly diagnosed NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML). The data, to be presented at the 2026 EHA Congress, showed high composite complete response (CRc) rates of 96% for NPM1-m and 90% for KMT2A-r AML, along with deep measurable residual disease (MRD)-negativity rates over 80%. Responses demonstrated encouraging durability, with the median duration of CRc not reached in NPM1-m patients at approximately 15 months median follow-up. The company is advancing ziftomenib in its ongoing Phase 3 KOMET-017 trial, with potential for accelerated FDA review in 2028, and will host an investor call on June 3.
Key Highlights
- Ziftomenib in combination with 7+3 showed 96% CRc rate (47/49) for NPM1-m AML.
- Ziftomenib in combination with 7+3 showed 90% CRc rate (45/50) for KMT2A-r AML.
- MRD-negativity rates among CRc responders were 83% (39/47) for NPM1-m AML.
- MRD-negativity rates among CRc responders were 82% (32/39) for KMT2A-r AML.
- Median duration of CRc not reached for NPM1-m patients at 14.9 months median follow-up.
- Median duration of CRc was 11.2 months for KMT2A-r patients at 9.3 months median follow-up.
- Phase 3 KOMET-017 trial is enrolling, with potential for accelerated FDA review in 2028.
- Kura Oncology will host a virtual investor call on June 3, 2026, at 8:00 a.m. ET.