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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | magrolimab (ONO-7913) (CD47 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
Excerpt:
...- Individuals with confirmation of AML by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is...
Trial ID:
Source:
Title:
Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results
Published date:
09/13/2023
Excerpt:
Magrolimab with azacitidine was relatively well tolerated with promising efficacy in patients with AML ineligible for intensive induction chemotherapy, including those with TP53 mutations...
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.22.02604
Trial ID:
Source:
Title:
Tolerability and efficacy of the first-in-class anti-CD47 antibody magrolimab combined with azacitidine in frontline TP53m AML patients: Phase 1b results.
Published date:
06/02/2022
Excerpt:
...Median durations of CR and CR/CRi were 7.7 mos (95% CI: 4.7, 10.9) and 8.7 mos (95% CI: 5.3, 10.9), respectively. Median overall survival (OS) for the 72 pts was 10.8 mos (95% CI: 6.8, 12.8) with median follow up 8.3 mos. In high-risk frontline TP53m AML pts unsuitable for intensive chemotherapy, magrolimab+AZA showed durable responses and encouraging OS in a single-arm study.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.2022.40.16_suppl.7020
Trial ID:
Source:
Title:
Tolerability and efficacy of the first-in-class anti-CD47 antibody magrolimab combined with azacitidine in frontline TP53m AML patients: Phase 1b results.
Published date:
05/26/2022
Excerpt:
72 TP53m AML pts were treated (Table)...Median overall survival (OS) for the 72 pts was 10.8 mos (95% CI: 6.8, 12.8) with median follow up 8.3 mos...In high-risk frontline TP53m AML pts unsuitable for intensive chemotherapy, magrolimab+AZA showed durable responses and encouraging OS in a single-arm study.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.2022.40.16_suppl.7020
Trial ID:
Source:
Title:
330 The First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine Is Well-Tolerated and Effective in AML Patients: Phase 1b Results
Published date:
11/04/2020
Excerpt:
In TP53-mutant AML patients, 15/21 (71%) achieved an objective response; 10 (48%) achieved a CR, 4 (19%) with CRi, 1 (5%) with MLFS, 5 (24%) with SD, and 1 (5%) with PD. The median duration of response was 9.9 months (range 0.03+ to 15.1+ mo ongoing); 89% of patients continued in response at 6 months.
Secondary therapy:
azacitidine
