On Thursday, Aptose Biosciences Inc. (NASDAQ:APTO) announced that the Cohort Safety Review Committee monitoring Phase 1/2 TUSCANY trial of tuspetinib in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet) has approved escalating from 40 mg TUS to 80 mg TUS based on its favorable review of data from the first four patients in the trial.
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.
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