Servier is poised to go to market with a new indication after the Phase III trial of a trial of its leukemia drug in IDH1-mutated acute myeloid leukemia (AML) closed with positive results.
The global Agile trial ended with Tibsovo (ivosidenib tablets) in combination with azacitidine meeting both primary and key secondary endpoints in adults with previously untreated IDH1-mutated AML.
The double-blinded study tested the efficacy and safety of Tibsovo with azacitidine versus placebo and identified event-free survival (EFS) as the primary endpoint, defined based on the time from randomization until treatment failure, relapse from remission or death. Treatment failure meant the failure to achieve complete remission by the 24th week. The secondary endpoints were complete remission rate, or the percentage of participants who achieved a CR, overall survival, CR and complete remission with partial hematologic recovery (CRh) rate and objective response rate. Read more here.