Positive Phase III study of Tibsovo in AML

Independent French pharma major Servier today announced the global Phase III double blinded placebo controlled AGILE study of Tibsovo (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS).

Treatment with Tibsovo in combination with azacitidine compared to azacitidine in combination with placebo demonstrated a statistically-significant improvement in EFS. Additionally, the trial met all of its key secondary endpoints, including complete remission rate (CR rate), overall survival (OS), CR and complete remission with partial hematologic recovery rate (CRh rate) and objective response rate (ORR). The safety profile of Tibsovo in combination with azacitidine was consistent with previously published data. The study recently halted further enrollment based on the recommendation of the Independent Data Monitoring Committee (IDMC), as a difference of clinical importance was noted between the treatment groups.

"The results of AGILE represent a major breakthrough and will be welcome news for patients dealing with previously untreated IDH1-mutated acute myeloid leukemia," said Claude Bertrand, executive vice president, R&D, Servier Group, adding: "We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world."