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NCT05735184 (Ziftomenib in R/R NPM1-m Acute Myeloid Leukemia): BVCT ex-ante prediction vs. reported outcome

On 26 Oct 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 5 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably insufficient (as monotherapy).

Clinical Trial

NCTID
NCT05735184
Acronym
KOMET-007
Drug Name
Ziftomenib
Drug MoA
MENIN-MLL1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
R/R NPM1-m Acute Myeloid Leukemia
Human Patients
212
Sponsor
Kura Oncology
Phase
Phase 1

Prediction of , index 1087

Prospective Prediction
Prediction Index
1087
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in CR/EFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
102 days in advance
Readout Data Interpretation
ziftomenib achieved statistically significant CR/CRh without disclosing the actual CR/CRh data (which usually indicates unremarkable results); probably inferior to venetoclax + azacitidine's 24-38% CR/CRh (see the add'l link below) combotherapy TBD
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient (as monotherapy)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia
Phase
Phase 1
Status
Recruiting
Enrollment
420
Lead sponsor
Kura Oncology, Inc.
Conditions
Acute Myeloid Leukemia; Mixed Lineage Leukemia Gene Mutation; Refractory AML; AML With Mutated NPM1; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, in Relapse; NPM1 Mutation; KMT2Ar; Myeloid Sarcoma; Nucleophosmin 1-mutated Acute Myeloid Leukemia
Interventions
DRUG: Ziftomenib; DRUG: Venetoclax; DRUG: Azacitidine; DRUG: Daunorubicin; DRUG: Cytarabine; DRUG: Quizartinib
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2023-07-18
Primary completion
2030-04
Completion
2030-04
Primary outcomes
  • Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only) (During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle))
  • Descriptive statistics of adverse events (From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment)
  • Complete remission (CR) rate (Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first)

NCT05735184 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials