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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + pevonedistat (MLN4924) (NEDD8 activating enzyme inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A phase 1/2 study of azacitidine, venetoclax and pevonedistat in newly diagnosed secondary AML and in MDS or CMML after failure of hypomethylating agents
Published date:
07/08/2023
Excerpt:
In the AML cohort, the median age was 74 years (range 61-86 years), and 27 patients (84%) had at least one adverse risk cyto-molecular feature, including 15 (47%) with a TP53 mutation or MECOM rearrangement; seventeen patients (53%) had received prior therapy for a preceding myeloid disorder. The CR/CRi rate was 66% (CR 50%; CRi 16%), and the median overall survival (OS) was 8.1 months...The triplet combination of azacitidine, venetoclax and pevonedistat shows encouraging activity in this very poor-risk population of patients with AML...
Secondary therapy:
azacitidine
DOI:
0.1186/s13045-023-01476-8
Trial ID:
Source:
Title:
Azacitidine, Venetoclax and Pevonedistat As Frontline Therapy for Patients with Secondary Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy: Results from a Phase I/II Study
Published date:
11/04/2021
Excerpt:
Responses were observed across subgroups, including in 8/14 pts (57%) with prior HMA/chemotherapy exposure, 6/8 pts (75%) with TP53 mutation...The combination of azacitidine, venetoclax and pevonedistat was safe and effective in a very poor-risk population of pts with s-AML...
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2021-153682
Source:
Title:
PRELIMINARY RESULTS OF A PHASE I/II STUDY OF AZACITIDINE, VENETOCLAX AND PEVONEDISTAT IN PATIENTS WITH SECONDARY ACUTE MYELOID LEUKEMIA WHO ARE UNFIT FOR INTENSIVE CHEMOTHERAPY
Published date:
06/12/2020
Excerpt:
The population was very poor-risk, including 8 pts (80%) with adverse-risk cytogenetics, 3 pts (30%) with prior hypomethylating (HMA) exposure, and 4 pts (40%) with TP53 mutation. CR/CRis were seen across disease subgroups, including in 2/3 pts with prior HMA exposure, 3/4 pts with TP53 mutation...The combination of azacitidine, venetoclax and pevonedistat is safe and shows encouraging preliminary efficacy in a very high-risk population of pts with s-AML.
Secondary therapy:
azacitidine
