Phase 3 to be Initiated
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TITLE: Vorasidenib for Low-Grade Glioma Phase 3 to be Initiated
Clinical Trial (NCT04164901) Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
WHAT IS THE NEXT CATALYST EVENT?
Phase 3 To be Initiated
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
11-22-2019 Agios Presents New Pharmacodynamic and Response Data from Both Cohorts of the Perioperative Study of Vorasidenib and TIBSOVO® (ivosidenib) in Patients with IDH1 Mutant Positive Low-Grade Glioma
05-30-2020 INDIGO: A global, randomized, double-blind, phase III study of vorasidenib (VOR; AG-881) vs placebo in patients with residual or recurrent grade II glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation
MECHANISM OF ACTION
Vorasidenib is an investigational, orally available, selective dual inhibitor of the mutated IDH1 and IDH2 proteins.
In early clinical studies, vorasidenib demonstrated full blood-brain barrier penetrance, robust suppression of the oncometabolite 2-HG and encouraging preliminary efficacy. Vorasidenib is currently being studied in the registration-enabling Phase 3 INDIGO study in patients with IDH-mutant low-grade glioma.
Updated by MV
IDH1, IDH2, GLioma, low-grade glioma, AGIO, Agios, vorasidenib
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