Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma.

ABSTRACT:

Background

Isocitrate dehydrogenase (IDH)-mutant grade 2 gliomas are malignant brain tumors that cause considerable disability and premature death. Vorasidenib, an oral brain-penetrant inhibitor of mutant IDH1 and IDH2 enzymes, showed preliminary activity in IDH-mutant gliomas.

Methods

In a double-blind, phase 3 trial, we randomly assigned patients with residual or recurrent grade 2 IDH-mutant glioma who had undergone no previous treatment other than surgery to receive either oral vorasidenib (40 mg once daily) or matched placebo in 28-day cycles. The primary end point was imaging-based progression-free survival according to blinded assessment by an independent review committee. The key secondary end point was the time to the next anticancer intervention. Crossover to vorasi

SUBMITTER: Mellinghoff IK 

PROVIDER: S-EPMC11445763 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature