Aptose announces first AML patients dosed in TUSCANY trial

Aptose Biosciences (APTO) announced dosing the first set of patients in the TUSCANY Phase 1/2 study with tuspetinib in combination with venetoclax and azacitidine as a frontline triple drug combination therapy for patients newly diagnosed with acute myeloid leukemia, or AML. The TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax for patients with AML who are ineligible to receive induction chemotherapy. TUS will be administered in 28-day cycles, beginning at 40mg once daily, with dose escalations planned after a safety review of each dose level. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. “We’re excited that our first several patients on the TUSCANY trial have received TUS+VEN+AZA,” said Rafael Bejar, MD, PhD, Aptose’s Chief Medical Officer. “TUS+VEN+AZA triplet therapy holds the promise of delivering high response rates and longer survival to newly diagnosed AML patients, while avoiding toxicities seen with other agents, thereby broadening the application of triplet therapy to more AML patients, including those with adverse disease features.”