Ghassan K. Abou-Alfa, MD, discusses the efficacy of ivosidenib in IDH1-mutant cholangiocarcinoma based on the results of the phase 3 ClarIDHy study.
Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the efficacy of Ivosidenib (Tibsovo) in IDH1-mutant cholangiocarcinoma based on the results of the phase 3 ClarIDHy study (NCT02989857).
The results of the study were positive, based on a primary end point of progression-free survival (PFS), which demonstrated clear disease suppression at 6 months and 12 months, Abou-Alfa says. Notably, 70% patients from the placebo arm crossed over to receive ivosidenib with a clear improvement in survival.
Patients on the ivosidinib arm experienced a significant improvement in median overall survival (OS) of up to 10.3 months, while patients on the placebo arm who did not crossover had a rank-preserving structural failure time–adjusted OS of 5.1 months, Abou-Alfa says. This translated to a doubling of survival, which is not ordinarily observed in cholangiocarcinoma, he says.
Additionally, the adverse effects associated with the agent were limited and quality of life was also in favor of ivosidenib, Abou-Alfa explains. Having wide availability of ivosidenib for patients with cholangiocarcinoma would be an exciting prospect, Abou-Alfa concludes.