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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | dubermatinib (TP-0903) (AXL inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A PHASE 1B/2 STUDY OF TP-0903 AND DECITABINE TARGETING MUTANT TP53 AND/OR COMPLEX KARYOTYPE IN PATIENTS WITH UNTREATED ACUTE MYELOID LEUKEMIA (AML) ≥ AGE 60 YEARS: FINAL RESULTS
Published date:
05/11/2023
Excerpt:
Newly diagnosed AML patients ≥60 years with TP53m and/or CK (defined as ≥3 abnormalities) were consented, screened and assigned to this Ph1b/2 study by the BeatAML Master Trial. A standard 3+3 design was used for Ph1b to determine the initial recommended dose of TP-0903 (Days 1-21, 37 mg/day) in combination with dec (Days 1-10, 20 mg/m2) in a 28-day cycle....The median overall survival was 7.6 months (95%CI, 2.0 – 20.6; median FU, 17.1 months) for all patients treated at 37mg and 7.5 months (95%CI, 1.1 – NE; median FU, 7.6 months) for those treated at 25 mg.
Secondary therapy:
decitabine
Trial ID:
Source:
Title:
TP-0903 Is Active in Preclinical Models of Acute Myeloid Leukemia with TP53 Mutation/Deletion
Published date:
12/21/2022
Excerpt:
The combination of TP-0903 and decitabine was additive in vitro, and in vivo significantly prolonged median survival compared to single-agent treatments in mice xenografted with HL-60 (vehicle, 46 days; decitabine, 55 days; TP-0903, 63 days; combination, 75 days) or MV4-11 (R248W) (51 days; 62 days; 81 days; 89 days) (p < 0.001). Together, these results provide scientific premise for the clinical evaluation of TP-0903 in combination with decitabine in TP53 mutant AML.
Secondary therapy:
decitabine
DOI:
10.3390/cancers15010029
