Tibsovo for cholngiocarcinoma – pro
The ClarIDHy trial was a global, randomized Phase III trial in previously treated IDH1 mutant cholangiocarcinoma patients whose disease had progressed after one or two systemic therapies. The trial involved 185 patients who were randomized 2:1 to receive either Tibsovo 500 mg once a day or a placebo with crossover to Tibsovo permitted at the time of documented radiographic progression.
Agios Pharmaceuticals, headquartered in Cambridge, Mass., announced that its Tibsovo (ivosidenib) hit its primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 (IDH1) mutation. The study ahd now been published by Ghassan et al and is standard of practice changing in that it is showing a PFS improvement with Tibsovo. Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
Tibsovo Prescribing Information 2019
Borger DR Tanabe KK Fan KC et al.
Frequent mutation of isocitrate dehydrogenase (IDH)1 and IDH2 in cholangiocarcinoma identified through broad-based tumor genotyping.
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https://www.nasdaq.com/press-release/agios-to-present-data-from-the-phase-3-claridhy-study-of-tibsovor-in-previously 2019
Ghassan K Abou-Alfaet al, Ivosidenib in IDH1-mutant, Chemotherapy-Refractory Cholangiocarcinoma (ClarIDHy): A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study Lancet Oncol . 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13.