Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

Inclusion Criteria:

• Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.

• 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%.

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

• Have had at least 1 prior surgery for glioma with the most recent one havingoccurred at least 1 year (-1 month) and not more than 5 years (+3 months) beforerandomization, and no other prior anticancer therapy, including radiotherapy and notbe in need of immediate chemotherapy or radiotherapy.

• 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

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

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.

• Concurrent active malignancy except for a) curatively resected nonmelanoma skincancer or b) curatively treated carcinoma in situ. Participants with previouslytreated malignancies are eligible provided they have been disease-free for 3 yearsat Screening.

• Have any other acute or chronic medical or psychiatric condition that may increasethe risk associated with the study participation or investigational productadministration or may interfere with the interpretation of study results.

• Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection,known positive human immunodeficiency virus antibody results, or AIDS-relatedillness. Participants with a sustained viral response to HCV treatment or immunityto prior HBV infection will be permitted. Participants with chronic HBV that isadequately suppressed by institutional practice will be permitted.