A Phase 1 Study of Milademetan in Combination With Quizartinib in Subjects With FLT3-ITD Mutant Acute Myeloid Leukemia That Are Relapsed/Refractory, or Newly Diagnosed and Unfit for Intensive Chemotherapy
Daiichi Sankyo's Phase 1 study of milademetan in combination with quizartinib targets FLT3-ITD mutant AML, a significant segment of the leukemia market. The combination therapy aims to enhance efficacy over monotherapy, potentially positioning Daiichi Sankyo favorably against competitors in the AML treatment landscape. However, the study was terminated based on a business decision, which raises concerns regarding the commercial viability and future investment in this asset. The termination may reflect strategic realignment or challenges in achieving desired clinical outcomes, necessitating careful diligence for stakeholders considering involvement in this therapeutic area.
Indication: Acute Myeloid Leukemia
Modality: small molecule
Target: FLT3-ITD mutation in Acute Myeloid Leukemia (AML)
Sponsor: Daiichi Sankyo
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 16, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: FLT3-ITD mutation in Acute Myeloid Leukemia (AML)
View original source fields
Condition raw: Acute Myeloid Leukemia
Condition normalized: Acute Myeloid Leukemia
Modality raw: small molecule
Modality normalized: small molecule
Target raw: FLT3-ITD mutation in Acute Myeloid Leukemia (AML)
Target normalized: FLT3-ITD mutation in Acute Myeloid Leukemia (AML)