CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has published the latest results of the global Phase III AGILE study for Tibsovo (ivosidenib) combined with azacitidine in newly diagnosed acute myeloid leukemia (AML) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Phase III AGILE Study Design and Findings
The double-blind, placebo-controlled global Phase III study aimed to assess the efficacy of ivosidenib combined with azacitidine in IDH1 mutation AML patients who are initially treated and not suitable for intensified chemotherapy. Long-term follow-up data as of June 2022 showed that at a median follow-up of 28.6 months, compared to azacytidine combined with placebo, ivosidenib combined with azacitidine significantly improved the overall survival (OS: 29.3 months vs. 7.9 months; 24-month OS rate: 53.1% vs. 17.4%). The safety data was consistent with the previously published data, indicating the well-tolerated profile of the combination therapy.
Tibsovo’s Development and Licensing History
Tibsovo was originally developed by US-based Agios, with CStone licensing commercial and development rights in Greater China to the drug in June 2018. The drug received approval in China in January 2022 to treat adult patients with relapsed or refractory acute myeloid leukemia (r/r AML) with IDH1 mutations. Servier acquired the rights to the drug through the acquisition of Agios’ oncology business. In the US, Tibsovo was approved to treat newly diagnosed IDH1 mutant AML patients aged 75 or above, or patients with comorbidities who cannot receive intensive induction chemotherapy; IDH1 mutation recurrence or refractory AML patients; and treated, locally advanced, or metastatic IDH1 mutation cholangiocarcinoma patients.-Fineline Info & Tech
