Kronos Bio, Inc., a company dedicated to transforming the lives of those affected by cancer, and Invivoscribe, a global provider of diagnostic kits and services for oncology, announced their agreement to develop a companion diagnostic (CDx) for use with Kronos Bio’s investigational therapy, entospletinib. Entospletinib is Kronos Bio’s lead clinical compound, currently in the ongoing Phase 3 registrational AGILITY study for the treatment of newly diagnosed NPM1-mutated acute myeloid leukemia (AML).
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The diagnostic will screen for the NPM1 mutation, which is present in approximately one-third of all patients with AML.
Over the past year, the two companies have worked together to develop and advance the diagnostic and prepare to submit the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) at the same time as the submission of the entospletinib New Drug Application (NDA). The FDA requires the validation and approval of companion diagnostics used to select patients for treatment with a specific therapeutic agent.
The agreement builds on Invivoscribe’s experience in developing and obtaining approval for diagnostics used for identification of patients with genetically mutated AML. Invivoscribe markets an FDA-approved CDx for FLT3-mutated AML.
“This companion diagnostic NPM1 mutation assay development work with Kronos Bio represents a significant milestone for our company,” said Jeffrey Miller, Ph.D., chief scientific officer and chief executive officer of Invivoscribe. “Companion diagnostics play a key role in the development and approval of targeted drug therapies and these kinds of partnerships are critical to improving care for patients with cancer.”
Kronos Bio’s AGILITY trial is designed to assess the efficacy and safety of entospletinib in approximately 180 adults who have been newly diagnosed with NPM1-mutated AML. In the trial, patients are being randomized to receive entospletinib or placebo, in combination with standard induction and consolidation chemotherapy. The primary endpoint of the trial is measurable residual disease (MRD) negative complete response. Event-free survival (EFS) is a key secondary endpoint, and mature EFS data are anticipated to be used to support potential full approval.