Core Insights - Aptose Biosciences Inc. presented data from its Phase 1/2 TUSCANY trial for newly diagnosed AML patients treated with tuspetinib in combination with venetoclax and azacitidine at the EHA 2025 Congress [1][3] Group 1: Study Overview - The TUS+VEN+AZA triplet is being developed as a mutation-agnostic frontline therapy for newly diagnosed AML patients who cannot receive induction chemotherapy [2][8] - The TUSCANY trial is designed to test various doses of tuspetinib in combination with standard dosing of azacitidine and venetoclax [9] Group 2: Key Findings - The addition of tuspetinib to standard care creates a well-tolerated and mutation-agnostic frontline therapy for newly diagnosed AML [5] - Ten AML patients have been treated with the TUS+VEN+AZA combination, with complete remissions and minimal residual disease negativity observed across diverse mutations [6][7] - At the 40 mg dose level, three out of four patients achieved complete remissions and were MRD-negative, while at the 80 mg dose level, all three patients achieved composite complete remissions [6] Group 3: Safety and Efficacy - No dose-limiting toxicities (DLTs) have been observed to date, and all ten subjects treated remain alive [6][7] - TUS demonstrated activity across diverse genetic populations, including those with adverse TP53 mutations [6][8] - The triplet therapy continues to be well tolerated, with no treatment-related deaths or significant adverse events reported [6][7]