A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
Pfizer's glasdegib is being evaluated in a pivotal Phase 3 trial for the treatment of previously untreated acute myeloid leukemia (AML) in both intensive and non-intensive chemotherapy settings. The dual approach targeting both intensive and non-intensive populations positions glasdegib favorably in a competitive landscape where treatment options for AML are limited. The market for AML therapies is growing, driven by an increasing incidence of the disease and the need for novel therapies that improve survival rates. Successful outcomes from this trial could enhance Pfizer's portfolio in hematologic malignancies and provide a significant competitive edge against existing therapies, particularly in patients who are not candidates for intensive chemotherapy. Diligence should focus on the trial's overall survival (OS) and complete remission (CR) rates, as these will be critical for regulatory approval and market uptake.
Indication: Leukemia, Myeloid, Acute
Modality: small molecule
Target: Hedgehog signaling pathway inhibition via glasdegib (PF-04449913)
Sponsor: Pfizer
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jun 23, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Hedgehog signaling pathway inhibition via glasdegib (PF-04449913)
View original source fields
Condition raw: Leukemia, Myeloid, Acute
Condition normalized: Leukemia, Myeloid, Acute
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Hedgehog signaling pathway inhibition via glasdegib (PF-04449913)
Target normalized: Hedgehog signaling pathway inhibition via glasdegib (PF-04449913)