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Association details:
| Biomarker: | TP53 wild-type |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | siremadlin (HDM201) (MDM2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia
Published date:
12/03/2021
Excerpt:
This phase I, dose-escalation study investigated the recommended dose for expansion (RDE) of siremadlin, a p53–MDM2 inhibitor, in patients with wild-type TP53 advanced solid or hematologic cancers. Overall, 115 patients with solid tumors and 93 with hematologic malignancies received treatment. Overall response rates at the RDEs were 10.3% [95% confidence interval (CI), 2.2–27.4] in solid tumors and 4.2% (95% CI, 0.1–21.1), 20% (95% CI, 4.3–48.1), and 22.2% (95% CI, 8.6–42.3) in acute myeloid leukemia (AML) in 1B, 1A, and 2C, respectively.
DOI:
10.1158/1078-0432.CCR-21-1295
Trial ID:
