Tibsovo Gets A Win In AML Following Servier Takeover

Positive Phase III topline results follow the US FDA’s acceptance of the drug in cholangiocarcinoma and encouraging data in low-grade glioma at ASCO 2021.

Acute myeloid leukemia a 3d-Render
Servier announced results from the Phase III AGILE study of Tibsovo in IDH1-mutant AML • Source: Shutterstock

Les Laboratoires Servier SAS has added to a string of incremental wins for the drug Tibsovo (ivosidenib) since the company bought the rights from Agios Pharmaceuticals, Inc. near the end of 2020, with new positive topline Phase III results in acute myeloid leukemia (AML), though it will be entering a field with steep competition.

Paris-based Servier said 2 August that topline results of AGILE showed that Tibsovo combined with Bristol Myers Squibb Company’s Vidaza (azacitidine) improved event-free survival (EFS), the trial’s primary endpoint, as well as producing improvements on key secondary endpoints like complete remission (CR) rate, objective response rate (ORR) and overall survival (OS)

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