Aptose Biosciences Inc. Presents Clinical Data from TUSCANY Phase 1/2 Trial

Aptose Biosciences Inc. announced updated safety and efficacy data from the TUSCANY Phase 1/2 trial of tuspetinib (TUS) in combination with venetoclax and azacitidine (TUS+VEN+AZA triplet) for newly diagnosed AML patients. The triplet therapy is being developed as a mutation-agnostic frontline treatment for patients ineligible for induction chemotherapy. The data, presented at the 2026 EHA Congress, showed a composite complete response (CRc) rate of 86.2% in evaluable patients across all dosing groups. Minimal residual disease (MRD)-negativity was achieved in 86.4% of patients who attained a CR/CRh response. The combination was found to be well-tolerated, with no treatment-related deaths or significant adverse events such as QTc prolongation, CPK elevations, or differentiation syndrome. Responses were observed across diverse genetic profiles, including TP53-mutated patients. The TUS+VEN+AZA triplet demonstrated activity in newly diagnosed AML patients regardless of mutation status, with responses continuing to evolve in patients remaining on treatment.