Dr. Zhu on the OS Results of the ClarIDHy Trial in IDH1+ Cholangiocarcinoma

Andrew Zhu, MD, PhD, director, Liver Cancer Research, Massachusetts General Hospital, professor of medicine, Harvard Medical School, discusses the final overall survival (OS) results from the phase 3 ClarIDHy trial in previously treated patients with IDH1-mutated cholangiocarcinoma.

According to findings presented during the 2021 Gastrointestinal Cancers Symposium, the median OS was 10.3 months with ivosidenib (Tibsovo) versus 7.5 months with placebo in this patient population, reflecting a hazard ratio (HR) of 0.79 (P = .093), Zhu explains.

Notably, crossover was permitted to the ivosidenib arm if patients experienced radiographic progression with placebo. In total, 70% of patients receiving placebo crossed over to ivosidenib. According to the rank-preserving structural failure time model, the crossover-adjusted OS was 5.1 months with placebo, reflecting an HR of 0.49 (P < .0001), concludes Zhu.