Final overall survival efficacy results of ivosidenib for patients with advanced cholangiocarcinoma with IDH1 mutation – The phase 3 randomized clinical ClarIDHy trial
This is the report of final overall survival (OS) results from the randomized phase 3 ClarIDHy trial, demonstrating the efficacy of ivosidenib vs placebo for patients with unresectable or metastatic cholangiocarcinoma with IDH1 mutation. 187 patients were randomized 2:1 to ivosidenib (N=126) or placebo (N=61); 43 patients crossed over from placebo to ivosidenib. Median OS was 10.3 months (95%CI 7.8-12.4 months) with ivosidenib vs 7.5 months (95%CI 4.8-11.1 months) with placebo (HR 0.79, 95%CI 0.56-1.12, P=0.09). When adjusted for crossover, median OS with placebo was 5.1
months (95%CI 3.8-7.6 months; HR 0.49, 95%CI 0.34-0.70, P<0.001). The most common grade ³3 treatment-emergent adverse event (TEAE) in both groups was ascites (11 patients [9%] receiving ivosidenib, 4 patients [7%] receiving placebo). Serious ivosidenib related-TEAEs were reported in 3 patients (2%). Patients receiving ivosidenib reported no decline in quality of life compared with placebo.
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.