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Agios Announces Publication of TIBSOVO® Phase 3 Data in The Lancet Oncology Demonstrating Significant Improvement in Progression-Free Survival Compared to Placebo in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients
– TIBSOVO® Is the First and Only IDH1 Inhibitor to Be Evaluated in a Phase 3 Clinical Trial for IDH1-Mutant Cholangiocarcinoma – CAMBRIDGE, Mass., May 19,
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– TIBSOVO® Is the First and Only IDH1 Inhibitor to Be Evaluated in a Phase 3 Clinical Trial for IDH1-Mutant Cholangiocarcinoma –\n CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that The Lancet Oncology has published data from its global Phase 3 ClarIDHy study of TIBSOVO® (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation. The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO® compared with placebo patients. The safety profile observed in the study was consistent with previously published data. Data from this study were previously presented at the European Society for Medical Oncology Congress (ESMO), held in September 2019 in Barcelona, Spain. The publication can be accessed at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30157-1/fulltext “We began researching IDH inhibition as a potential therapeutic approach for solid tumors more than five years ago with the goal of innovating on behalf of patients, including those with advanced cholangiocarcinoma, who desperately need new treatment options,” said Chris Bowden, M.D., chief medical officer at Agios. “We are pleased that the ClarIDHy study supports the potential utility of TIBSOVO® for this patient population and are focused on filing our supplemental new drug application for previously treated IDH1-mutant cholangiocarcinoma patients between the end of this year and mid-2021.” ClarIDHy Phase 3 TrialThe ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting. Patients were randomized 2:1 to receive either single-agent TIBSOVO® 500 mg once daily or placebo with crossover to TIBSOVO® permitted at the time of documented radiographic progression per RECIST 1.1. At the time of the primary analysis, a total of 185 patients were randomized, with 124 patients in the TIBSOVO® arm and 61 patients in the placebo arm. Thirty-five patients randomized to placebo (57.4%) crossed...