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Eprenetapopt Plus Azacitidine in TP53-Mutated AML After Stem Cell Transplantation

By: Julia Fiederlein
Posted: Wednesday, January 5, 2022

Maintenance therapy with the small molecule p53 stabilizer eprenetapopt plus azacitidine seemed to be safe and active in patients with TP53-mutated acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who underwent allogeneic stem cell transplantation, according to Asmita Mishra, MD, of the H. Lee Moffitt Cancer Center and Research Institute, Tampa, and colleagues. The findings of this multicenter phase II trial were presented during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 409).

“The majority of reported treatment-related adverse events comprised known complications of patients with high-risk MDS and AML in the [post-transplant] period,” the investigators commented. “In addition, the observed relapse-free survival and overall survival data are highly encouraging compared with the historical outcomes.”

A total of 33 patients with TP53-mutated AML (n = 14) or MDS (n = 19) were enrolled. The median duration of relapse-free survival was 368 days, and the 1-year relapse-free survival rate was 58%. The median duration and 1-year rate of overall survival were 586 days and 79%, respectively.

Nausea (61%), decreased platelet count (49%), vomiting (46%), anemia (39%), dizziness (39%), decreased white blood cell count (39%), fatigue (36%), diarrhea (33%), tremor (33%), cough (24%), decreased neutrophil count (24%), pruritus (24%), pyrexia (24%), abdominal pain (21%), constipation (21%), decreased appetite (21%), headache (21%), and hypocalcemia (21%) were the most frequently reported all-grade treatment-emergent adverse events. The most common treatment-emergent adverse events of grade 3 or higher were decreased platelet count (36%), decreased white blood cell count (33%), anemia (27%), decreased neutrophil count (24%), thrombocytopenia (12%), and hypertension (12%). Serious adverse events reported in at least two patients were pyrexia (12%), febrile neutropenia (6%), and dyspnea (6%). Two patients (6%) discontinued study treatment due to treatment-emergent adverse events. A total of 12% and 30% of patients experienced acute and chronic graft-versus-host disease events, respectively.

Disclosure: For full disclosures of the study authors, visit

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