Article
Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial.
The Lancet. Oncology - 1 Dec 2025
Cloughesy Timothy F, van den Bent Martin J, Touat Mehdi, Blumenthal Deborah T, Peters Katherine B, Ellingson Benjamin M, Clarke Jennifer L, Mendez Joe, Yust-Katz Shlomit, Welsh Liam, Mason Warren P, Ducray Francois, Umemura Yoshie, Nabors Burt, Holdhoff Matthias, Hottinger Andreas F, Arakawa Yoshiki, Sepulveda Juan M, Wick Wolfgang, Soffietti Riccardo, Perry James, Giglio Pierre, de la Fuente Macarena, Maher Elizabeth, Bottomley Andrew, Tron Adriana E, Yi Denise, Zhao Dan, Pandya Shuchi S, Steelman Lori, Hassan Islam, Wen Patrick Y, Mellinghoff Ingo K
Abstract excerpt
BACKGROUND: In a phase 3 trial, vorasidenib, an oral brain-penetrant inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2), resulted in improved progression-free survival (primary endpoint) and time to next intervention (key secondary endpoint) at second interim analysis, resulting in study unblinding. We report 6 months of additional double-blind data, from second interim analysis (Sept 6, 2022) to...
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