The TUS+VEN+AZA triplet is being developed as a frontline therapy to treat large, mutationally diverse populations of newly diagnosed acute myeloid leukemia (AML) patients who are ineligible to receive induction chemotherapy.
No significant safety concerns or dose-limiting toxicities (DLTs) have been reported, including no prolonged myelosuppression of subjects in remission. All four subjects treated in the 40 mg cohort remain in the study, while enrollment is open for the 80 mg cohort.
Multiple U.S. sites are enrolling in the TUSCANY trial, with an anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available.
Three patients with unmutated (wildtype) FLT3 (FLT3-WT) completed Cycle 1 of treatment with no dose-limiting toxicities (DLTs) and no TUS dose adjustments. Two FLT3-WT patients achieved complete remissions (CR and CRh) by the end of Cycle 1. A patient with biallelic TP53 mutations and a complex karyotype obtained CR.
The third FLT3-WT patient experienced significant reductions in bone marrow leukemic blasts during Cycle 1 and remains on therapy in Cycle 2.
The fourth patient, harboring FLT3-ITD and NPM1 mutations, is currently dosing in Cycle 1 and is not yet eligible for response evaluation.
Pharmacokinetic (PK) analyses for TUS show plasma levels unaffected by adding AZA.
Price Action: APTO stock is up 31.50% at $0.20 at last check Thursday.
Read Next:
Photo by Aunt Spray via Shutterstock
© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
To add Benzinga News as your preferred source on Google, click here.
