Patients with refractory or relapsed acute myeloid leukemia (R/R AML) have a poor prognosis, with a high unmet medical need. Idasanutlin is a small-molecule inhibitor of MDM2, a negative regulator of tumor suppressor p53. By preventing the p53-MDM2 interaction, idasanutlin allows for p53 activation, particularly in patients with TP53 wild-type (WT) status. MIRROS (NCT02545283) is a randomized Phase III trial evaluating idasanutlin + cytarabine versus placebo + cytarabine in R/R AML. The primary end point is overall survival in the TP53-WT population. Secondary end points include complete remission rate (cycle 1), overall remission rate (cycle 1) and event-free survival in the TP53-WT population. MIRROS has an innovative design that integrates a stringent interim analysis for futility; continuation criteria were met in mid-2017 and accrual is ongoing.Trial registration number: NCT02545283
Montesinos, P., Beckermann, B.M., Catalani, O., Esteve, J., Gamel, K., Konopleva, M.Y., et al. (2020). MIRROS: A Randomized, Placebo-Controlled, Phase III Trial of Cytarabine ± Idasanutlin in Relapsed or Refractory Acute Myeloid Leukemia. FUTURE ONCOLOGY, 16(13), 807-815 [10.2217/fon-2020-0044].
MIRROS: A Randomized, Placebo-Controlled, Phase III Trial of Cytarabine ± Idasanutlin in Relapsed or Refractory Acute Myeloid Leukemia
Martinelli, Giovanni;Papayannidis, Cristina;
2020
Abstract
Patients with refractory or relapsed acute myeloid leukemia (R/R AML) have a poor prognosis, with a high unmet medical need. Idasanutlin is a small-molecule inhibitor of MDM2, a negative regulator of tumor suppressor p53. By preventing the p53-MDM2 interaction, idasanutlin allows for p53 activation, particularly in patients with TP53 wild-type (WT) status. MIRROS (NCT02545283) is a randomized Phase III trial evaluating idasanutlin + cytarabine versus placebo + cytarabine in R/R AML. The primary end point is overall survival in the TP53-WT population. Secondary end points include complete remission rate (cycle 1), overall remission rate (cycle 1) and event-free survival in the TP53-WT population. MIRROS has an innovative design that integrates a stringent interim analysis for futility; continuation criteria were met in mid-2017 and accrual is ongoing.Trial registration number: NCT02545283I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
