Profile Response Detail


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Molecular Profile IDH1 R132L
Therapy Ivosidenib
Indication/Tumor Type cholangiocarcinoma
Response Type predicted - sensitive


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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 R132L cholangiocarcinoma predicted - sensitive Ivosidenib FDA approved - On Companion Diagnostic Actionable In a Phase III (ClarIDHy) trial that supported FDA approval, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/H/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857). detail... 32416072 detail...
PubMed Id Reference Title Details
Full reference...
Tibsovo (ivosidenib) FDA Drug Label Full reference...
(32416072) Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Full reference...