Kronos Bio Announces Phase III Trial of Entospletinib in NPM1-Mutated AML

Kronos Bio says it has reached an agreement with the U.S. Food and Drug Administration (FDA) to launch a phase III clinical trial evaluating its selective spleen tyrosine kinase inhibitor entospletinib for the treatment of patients with NPM1-mutated acute myeloid leukemia (AML) with a primary endpoint of measurable residual disease (MRD) negativity.

Kronos Bio’s trial – the first to test a treatment’s efficacy in patients with AML based on a faster endpoint of MRD-negativity instead of overall survival or time to relapse – will enroll 180 adult patients with newly diagnosed NPM1-mutated AML.

While a formal Special Protocol Assessment agreement has not been established, a Kronos Bio spokesperson said the company “would not have proceeded with this clinical trial design unless we had sign-off from the FDA.”

Early-stage results showed 87% of patients with NPM1-mutated AML who were treated with a combination of entospletinib and standard chemotherapy experienced complete remission.

Source: STAT, March 4, 2021.