INDIGO — Vorasidenib Versus Placebo in Residual or Recurrent Grade 2 IDH-Mutant Glioma After Surgery

Phase 3 · 2023 · Glioma

Design

Randomized double-blind to oral vorasidenib vs placebo, with crossover permitted at imaging-confirmed progression.

Population

Residual or recurrent grade 2 IDH1- or IDH2-mutant astrocytoma or oligodendroglioma after surgery, not requiring immediate chemotherapy or radiotherapy.

Primary Endpoint

imaging-based progression-free survival (PFS)

Key Result

Median PFS 27.7 vs 11.1 mo (HR 0.39); time to next intervention markedly delayed.

Guideline Impact

Supported vorasidenib for residual or recurrent grade 2 IDH-mutant glioma after surgery