Aptose Announces First AML Patients Dosed with Tuspetinib Triplet Frontline Therapy in TUSCANY Trial

Core Viewpoint - Aptose Biosciences has initiated dosing for the first patients in the TUSCANY Phase 1/2 study, evaluating the triplet therapy of tuspetinib (TUS), venetoclax (VEN), and azacitidine (AZA) for newly diagnosed acute myeloid leukemia (AML) patients [1][2][3] Group 1: Study Details - The TUSCANY Phase 1/2 trial aims to establish an improved frontline therapy for newly diagnosed AML patients, focusing on safety, durability, and broad activity across diverse AML populations [2][4] - The trial will test various doses and schedules of TUS in combination with standard doses of azacitidine and venetoclax, with TUS starting at 40mg once daily in 28-day cycles [4] - Enrollment is expected to include 18-24 patients by mid to late 2025 across multiple U.S. sites [4] Group 2: Drug Efficacy and Safety - Previous APTIVATE trials indicated that TUS as a single agent and in combination with VEN showed favorable safety and broad activity in relapsed or refractory AML populations, including those with adverse mutations [2][3] - The triplet therapy is anticipated to deliver high response rates and longer survival for newly diagnosed AML patients while minimizing toxicities associated with other treatments [3] Group 3: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [6] - The lead clinical-stage oral kinase inhibitor, tuspetinib, has shown promise as both a monotherapy and in combination therapy for AML [6]