BioCentury
ARTICLE | Clinical News

AT-406: Phase I data

August 4, 2014 7:00 AM UTC

An open-label, U.S. Phase I trial in 29 AML patients showed that once-daily 100, 200, 300 or 400 mg oral Debio 1143 plus daunorubicin and cytarabine led to complete remission in 13 patients. Of those 13 patients, 8 relapsed. The most common treatment-related adverse events were nausea, diarrhea and febrile neutropenia. There were dose-limiting toxicities (DLTs) in 3 patients, including grade 3/4 elevated alanine aminotransferase (ALT) and aspartate aminotransaminase (AST) levels, grade 3 mucositis and neutropenic fever and grade 4 heart failure. Debiopharm said the efficacy data are “inconclusive,” but warrant further studies in subsets of patients with AML. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...