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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | eprenetapopt (APR-246) (p53 reactivator) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Aprea Therapeutics Receives FDA Fast Track Designation for Eprenetapopt in the Treatment of TP53 Mutant Acute Myeloid Leukemia (AML)
Published date:
11/30/2020
Excerpt:
Aprea Therapeutics, Inc....announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukemia (AML).
Source:
Title:
APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
Excerpt:
...To Assess Relapse-free Survival (RFS) in Patients With TP53 Mutated AML or MDS After Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HSCT)....
Trial ID:
Source:
Title:
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
Excerpt:
...Documentation of a TP53 gene mutation by next-generation sequencing (NGS) based on central or local evaluation....
Trial ID:
More C2 evidence
Source:
Title:
Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms
Excerpt:
...- Documentation of a TP53 gene mutation by NGS based on central or local evaluation....
Trial ID:
Less C2 evidence
Source:
Title:
39 - Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Following Allogeneic Hematopoietic Cell Transplantation (HCT)
Published date:
02/11/2022
Excerpt:
...maintenance therapy with eprenetapopt in combination with AZA was safe and tolerable with favorable results in patients with TP53 mutant MDS and AML.
Secondary therapy:
azacitidine
Source:
Title:
Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)
Published date:
11/04/2021
Excerpt:
...eprenetapopt in combination with AZA was safe and tolerable with favorable results in patients with TP53 mutant MDS and AML…
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2021-147962
Source:
Title:
Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML
Published date:
07/21/2021
Excerpt:
Aprea Therapeutics, Inc....today announced positive results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML....In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 58% and the median RFS was 12.1 months. The overall survival (OS) at 1 year post-transplant was 79%, with a median OS of 19.3 months
Secondary therapy:
azacitidine
Source:
Title:
Eprenetapopt Plus Azacitidine in TP53-Mutated Myelodysplastic Syndromes and Acute Myeloid Leukemia: A Phase II Study by the Groupe Francophone des Myélodysplasies (GFM)
Published date:
02/18/2021
Excerpt:
With a median follow-up of 9.7 months, median OS was 12.1 months in MDS, and 13.9 and 3.0 months in AML with less than and more than 30% marrow blasts, respectively….In this very high-risk population of TP53m MDS and AML patients, eprenetapopt combined with AZA was safe and showed potentially higher ORR and CR rate, and longer OS than reported with AZA alone.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.20.02342
Trial ID:
Source:
Title:
Eprenetapopt (APR-246) and Azacitidine in TP53-Mutant Myelodysplastic Syndromes
Published date:
01/15/2021
Excerpt:
...Fifty-five patients (40 MDS, 11 AML, and four MDS/myeloproliferative neoplasms) with at least one TP53 mutation were treated. The overall response rate was 71% with 44% achieving CR. Of patients with MDS, 73% (n = 29) responded with 50% (n = 20) achieving CR and 58% (23/40) a cytogenetic response. The overall response rate and CR rate for patients with AML was 64% (n = 7) and 36% (n = 4), respectively. Patients with only TP53 mutations by next-generation sequencing had higher rates of CR (69% v 25%; P = .006)...Combination treatment with eprenetapopt and azacitidine is well-tolerated yielding high rates of clinical response and molecular remissions in patients with TP53-mutant MDS and oligoblastic AML..
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.20.02341
Trial ID:
Source:
Title:
Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
Published date:
11/06/2019
Excerpt:
APR-246+AZA is a well-tolerated combination with high response rates in mTP53 MDS/AML.
Secondary therapy:
azacitidine
DOI:
https://doi.org/10.1182/blood-2019-131055
