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Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.
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- Author(s): Abou-Alfa, Ghassan K1,2 (AUTHOR); Macarulla, Teresa3 (AUTHOR); Javle, Milind M4 (AUTHOR); Kelley, Robin K5 (AUTHOR); Lubner, Sam J6 (AUTHOR); Adeva, Jorge7 (AUTHOR); Cleary, James M8 (AUTHOR); Catenacci, Daniel V9 (AUTHOR); Borad, Mitesh J10 (AUTHOR); Bridgewater, John11 (AUTHOR); Harris, William P12 (AUTHOR); Murphy, Adrian G13 (AUTHOR); Oh, Do-Youn14 (AUTHOR); Whisenant, Jonathan15 (AUTHOR); Lowery, Maeve A16 (AUTHOR); Goyal, Lipika17 (AUTHOR); Shroff, Rachna T18 (AUTHOR); El-Khoueiry, Anthony B19 (AUTHOR); Fan, Bin20 (AUTHOR); Wu, Bin20 (AUTHOR)
- Source:
Lancet Oncology. Jun2020, Vol. 21 Issue 6, p796-807. 12p.- Subject Terms:
*ISOCITRATE dehydrogenase; *PROGRESSION-free survival; *ORAL diseases; *ADVERSE health care events; *PYRIDINE; *DISEASE progression; *RESEARCH; *GENETIC mutation; *GLYCINE; *CHOLANGIOCARCINOMA; *TIME; *RESEARCH methodology; *ANTINEOPLASTIC agents; *EVALUATION research; *MEDICAL cooperation; *COMPARATIVE studies; *RANDOMIZED controlled trials; *BLIND experiment; *RESEARCH funding; *OXIDOREDUCTASES; *STATISTICAL sampling; *ENZYME inhibitors; *DRUG resistance in cancer cells; *CHEMICAL inhibitors; BILIARY tract cancer; BILE duct tumors - Source:
- Additional Information
- Subject Terms:
- Abstract:
Background: Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.Methods: This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.Findings: Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.Interpretation: 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.Funding: Agios Pharmaceuticals. [ABSTRACT FROM AUTHOR] - Abstract: Copyright of Lancet Oncology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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