Cholangiocarcinoma Highlights: ASCO 2021

Companies and the scientific community have begun to present at ASCO21, and DelveInsight’s experts are keenly keeping track of their plans and presentations in the Cholangiocarcinoma. In the ocean of abstracts and reports from clinical studies, we have picked some of the most important ones. Have a look here.

Abstract 4069_TIBSOVO (ivosidenib/IVO)_Previously treated Cholangiocarcinoma (CCA) and isocitrate dehydrogenase 1 (IDH1) mutation_Servier

ClarIDHy Trial: Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation.

Servier presented a poster showing the final results from ClarIDHy, a global, phase 3 study of TIBSOVO (ivosidenib/IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation. The study represents the first phase III study of a targeted, oral therapeutic with a noncytotoxic mechanism of action in advanced IDH1-mutant cholangiocarcinoma. In the trial design, IVO treatment resulted in a numeric improvement in OS despite a high crossover from the placebo arm; additionally, the treatment demonstrated a highly statistically significant improvement in PFS compared to placebo. The PFS rate at 6-month and 12-month was found to be 32% and 22%, respectively, and median PFS was 2.7 months with ivosidenib and 1.4 months with placebo. The favorable overall survival trend became statistically significant after adjusting for the 70% of patients crossing over to ivosidenib after radiographic disease progression. In that adjusted analysis, the risk was reduced by 51%. Ivosidenib also resulted in a greater disease control rate than placebo [53% vs 28%]. The treatment effect on progression-free survival was consistent across subgroups. The company is happy to announce that these data served as a basis for the supplemental New Drug Application (sNDA), which was filed in March 2021. 

Expert Views "The progression-free and overall survival data coupled with a tolerable safety profile and supportive health-related quality of life data demonstrate the clinical benefit of ivosidenib in this aggressive disease, for which there is an unmet need for new therapies."

Looking at the energetic pace of the domain growth, DelveInsight believes that the Cholangiocarcinoma market growth is going to be buoyed with a CAGR of 12.71% in the 7MM (the US, EU5 and Japan) by 2030. Get in touch with us at info@delveinsight.com to discuss more.