Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program
Ziftomenib met its primary endpoint in the KOMET-001 Phase 2 trial for relapsed/refractory NPM1-mutant AML15.
Kura Oncology plans to submit a New Drug Application (NDA) to the FDA in Q2 202515.
Two Phase 3 trials (KOMET-017) are planned to start in H2 2025:
KOMET-017-IC:
Ziftomenib with intensive chemotherapy
KOMET-017-NIC:
Ziftomenib with venetoclax/azacitidine15
Both Phase 3 trials have dual-primary endpoints for potential accelerated and full FDA approval15.
Ziftomenib received Breakthrough Therapy Designation from the FDA in April 2024310.
The drug targets up to 50% of AML patients, including those with NPM1 mutations and KMT2A rearrangements15.
Positive combination data was reported from the KOMET-007 trial at the 2024 ASH Annual Meeting410.
Kura Oncology is collaborating with Kyowa Kirin for global commercialization of ziftomenib15.
The KOMET-017-IC trial will use MRD negative CR as an endpoint for potential accelerated approval, a novel approach in AML drug development1.
Multiple data readouts for ziftomenib and other pipeline programs are anticipated throughout 202515.
Sources:
1. https://www.stocktitan.net/news/KURA/kura-oncology-and-kyowa-kirin-announce-positive-ziftomenib-tomrcymfclmv.html
3. https://www.lls.org/research/kura-oncology-receives-breakthrough-therapy-designation-ziftomenib-npm1-mutant-aml
4. https://www.oncologypipeline.com/apexonco/ash-2024-jj-mounts-its-first-line-menin-challenge
5. https://www.globenewswire.com/news-release/2025/02/05/3021565/35186/en/Kura-Oncology-and-Kyowa-Kirin-Announce-Positive-Ziftomenib-Monotherapy-Registrational-Trial-and-Positive-FDA-Feedback-for-Upcoming-Frontline-Combination-Trial-Designs.html
10. https://www.biospace.com/press-releases/kura-oncology-and-kyowa-kirin-report-positive-combination-data-for-ziftomenib-at-american-society-of-hematology-annual-meeting