KRON - Kronos Bio to start Phase 3 trial for Entospletinib in AML

After receiving minutes from its End-of-Phase 2 meeting with the FDA, Kronos Bio, Inc. (KRON) announced that it will initiate a Phase 3 trial for entospletinib in mid-2021 in patients newly diagnosed with NPM1-mutated acute myeloid leukemia (AML).The primary endpoint will be measurable residual disease (MRD) negative complete response ("CR") as measured by next-generation sequencing. The MRD negative CR data are expected in the 2H 2023, the company said.The global, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of the selective spleen tyrosine kinase inhibitor will involve 180 patients newly diagnosed with NPM1-mutated AML.The patients will be randomized to receive entospletinib or placebo, in combination with standard induction and consolidation chemotherapy, for a minimum of two cycles.“As the first AML trial to use MRD negative CR as a primary endpoint, our trial is breaking new ground that may help deliver effective, targeted therapies more expeditiously to patients living with this

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Kronos Bio to start Phase 3 trial for Entospletinib in AML