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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + eprenetapopt (APR-246) (p53 reactivator) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Eprenetapopt combined with venetoclax and azacitidine in TP53-mutated acute myeloid leukaemia: a phase 1, dose-finding and expansion study
Published date:
03/30/2023
Excerpt:
Eprenetapopt and venetoclax with azacitidine had an acceptable safety profile and encouraging activity, supporting further frontline evaluation of this combination in the treatment of TP53-mutated acute myeloid leukaemia.
Secondary therapy:
azacitidine
DOI:
10.1016/S2352-3026(22)00403-3
Trial ID:
Source:
Title:
Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
Published date:
11/04/2021
Excerpt:
This is a multi-center, open-label, dose-finding and expansion study to determine the safety and preliminary efficacy of eprenetapopt in combination with VEN and AZA in TP53 mutant AML….There was 1 CR and 1 CRi among the 6 pts who received eprenetapopt + VEN....Eprenetapopt plus VEN with and without AZA was tolerated by pts as demonstrated by absence of DLTs across safety cohorts...
DOI:
10.1182/blood-2021-148940
Source:
Title:
Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
Published date:
11/04/2021
Excerpt:
This is a multi-center, open-label, dose-finding and expansion study to determine the safety and preliminary efficacy of eprenetapopt in combination with VEN and AZA in TP53 mutant AML….Preplanned efficacy analysis of the first 30 efficacy evaluable pts who received eprenetapopt + VEN + AZA demonstrated CR rate of 37% and CR +CRi rate of 53% with median duration 118 days (95% CI 60, NE) and 128 days (95% CI 57, NE), respectively....the triplet regimen demonstrated highly encouraging efficacy data and met the Simon-2 stage CR threshold...
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2021-148940
