Therapeutic Response

IDH1 p.R132G status confers therapeutic sensitivity to Ivosidenib in patients with Cholangiocarcinoma.

Statements

Source and description
Tibsovo (ivosidenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ivosidenib as a monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 variant who were previously treated with at least one prior line of systemic therapy.
Tibsovo (ivosidenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated with a susceptible IDH1 mutation, as detected by an FDA-approved test. This indication is based on Study AG120-C-005 (NCT02989857), a randomized, multicenter, double-blind, placebo-controlled clinical trial consisting of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The product label notes that, across both arms of the trial, patients primarily had R132 variants: R132C (70% of patients), R132L (15%), R132G (12%), R132H (1.1%), and R132S (1.6%).