Kura Oncology's ziftomenib shows 96% complete response in frontline AML and $5.8M in early commercial sales; updated FIT-001 trial data for kidney cancer to be presented at 2026 summit; analysts see significant upside with an average target of $32.45.
Updated KOMET-007 trial data show ziftomenib plus chemotherapy achieves 94% twelve-month overall survival in newly diagnosed NPM1-mutant AML. The oral menin inhibitor, approved by the FDA in November 2025 for relapsed/refractory disease, is being evaluated in a Japanese Phase II trial and a global Phase 3 study.
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07623616 |
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia |
RECRUITING | PHASE2 |
| NCT07411586 |
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT07007312 |
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML |
RECRUITING | PHASE3 |
| NCT06930352 |
Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT06448013 |
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia |
RECRUITING | PHASE1 |
| NCT06001788 |
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia |
RECRUITING | PHASE1 |
| NCT05848687 |
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II |
RECRUITING | PHASE1/PHASE2 |
| NCT05738538 |
Expanded Access to Ziftomenib |
AVAILABLE |
