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Association details:
| Biomarker: | RARA overexpression |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | azacitidine (DNA methylation inhibitor) + Amnolake (tamibarotene) (RARα agonist) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Use of tamibarotene, a potent and selective RARα agonist, in combination with azacitidine in patients with relapsed and refractory AML with RARA gene overexpression
Published date:
08/12/2023
Excerpt:
A phase 2 study investigating the activity of tamibarotene in patients with RARA overexpression was conducted in patients with AML and MDS (NCT02807558). In 28 patients with R/R AML and RARA overexpression treated with tamibarotene in combination with azacitidine, the median overall survival was 5.9 months. In 21 response-evaluable patients, the complete remission/complete remission with incomplete hematologic recovery (CR/CRi) rate was 19%, and median time to initial CR/CRi was 1.2 months.
DOI:
https://doi.org/10.1080/10428194.2023.2243356
Trial ID:
Source:
Title:
Targeting RARA overexpression with tamibarotene, a potent and selective RARα agonist, is a novel approach in AML
Published date:
04/28/2023
Excerpt:
The combination of oral tamibarotene plus azacitidine was evaluated in a phase 2 clinical study in 51 newly diagnosed unfit patients with AML identified as RARA-positive...The presence of RARA overexpression was characterized as RARA-positive...The 18 response-evaluable RARA-positive patients were evaluated for best OR (response definitions and results in Figure 3). The ORR was 67% (12/18), with a CR/CRi rate of 61% (9 CR, 2 CRi), a CR rate of 50%...
DOI:
10.1182/bloodadvances.2022008806
