Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Key Inclusion Criteria:

• Be at least 12 years of age and weigh at least 40 kg.

• Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.

• Have had at least 1 prior surgery for glioma (biopsy, sub-total resection,gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization,and no other prior anticancer therapy, including chemotherapy and radiotherapy andnot be in need of immediate chemotherapy or radiotherapy in the opinion of theInvestigator.

• Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2R172K/M/W/S/G mutation variants tested) gene mutation status disease by centrallaboratory testing during the Prescreening period and available 1p19q status bylocal testing (eg, fluorescence in situ hybridization [FISH], comparative genomichybridization [CGH] array, sequencing) using an accredited laboratory.

• Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC.

• Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age)or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.

Key Exclusion Criteria:

• Have had any prior anticancer therapy other than surgery (biopsy, sub-totalresection, gross-total resection) for treatment of glioma including systemicchemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors,investigational agents, laser ablation, etc.

• Have features assessed as high-risk by the Investigator, including brainsteminvolvement either as primary location or by tumor extension, clinically relevantfunctional or neurocognitive deficits due to the tumor in the opinion of theInvestigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).