CStone Pharmaceuticals announced that the company has presented the clinical data from the China registrational bridging study CS3010-101 of its first-in-class drug ivosidenib (TIBSOVO®, the brand name in the U.S.) in a proffered paper presentation at the 2021 European Society for Medical Oncology (ESMO) Congress. CS3010-101 is an ongoing phase I, multi-center, single-arm study in China, which aims to evaluate the pharmacokinetic (PK), pharmacodynamics (PD), safety, and clinical efficacy of orally administrated ivosidenib in Chinese adult patients with R/R AML with a susceptible IDH1 mutation. And as the bridging study of the global pivotal AG120-C-001 study, it provides data on R/R AML patients in China. Efficacy: ivosidenib demonstrated clinical efficacy in the treatment of Chinese adults with R/R AML with a susceptible IDH1 mutation: In 30 evaluable patients, the primary efficacy endpoint of complete remission plus complete remission with partial hematologic recovery (CR+CRh) rate was 36.7% (11/30, with all 11 patients achieving CR). The median time to CR+CRh was 3.68 months, and 12-month duration rate of CR+CRh is 90.9%. Two patients received hematopoietic stem cell transplantation (HSCT) after achieving responses of CR or CRh. The median event-free survival (EFS) was 5.52 months and the median overall survival (OS) was 9.10 months. Safety: ivosidenib was well tolerated and had a manageable safety profile; The incidence of Grade=3 treatment emergent adverse events (TEAEs) was 86.7%, and the incidence of TEAEs leading to permanent discontinuation was 10%. Ivosidenib had a well-tolerated safety profile, and no new safety signals were detected. Adverse events of special interest can be effectively monitored and controlled through protocol guidance and routine clinical management.