6/28/23, 11:35 PM INDIGO Pathway Feedback Search Clinical Topics Home Studies INDIGO INDIGO Disease Diffuse glioma Trial question What is the role of vorasidenib in patients with grade 2 IDH-mutant glioma? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.0% female N = 331 56.0% male 331 patients (144 female, 187 male) Inclusion criteria: patients with residual or recurrent grade 2 IDH-mutant glioma who had undergone no previous treatment other than surgery Key exclusion criteria: prior anticancer therapy other than surgery, presence of features assessed by the investigator as high risk, HR-corrected QT interval of at least 450 msec on the basis of Fridericia's formula Interventions N=168 vorasidenib (an oral dose of 40 mg/day in 28-day cycles) N=163 placebo (matching placebo oral tablets in 28-day cycles) Primary outcome Median progression-free survival 27.7 months 27.7 https://web.pathway.md/studies/recCbGqKxtZxlof1U 1/2 6/28/23, 11:35 PM INDIGO Pathway 20.8 months 13.8 months 11.1 6.9 months Significant increase 0.0 months Vorasidenib Placebo Significant increase in median progression-free survival (27.7 months vs. 11.1 months; AD 16.6 months, 95% CI 6.75 to 26.45) Safety outcomes No significant difference in adverse events. Significant differences in increased ALT (38.9% vs. 14.7%), increased AST (28.7% vs. 8.0%). Conclusion In patients with residual or recurrent grade 2 IDH-mutant glioma who had undergone no previous treatment other than surgery, vorasidenib was superior to placebo with respect to median progression-free survival. Reference Ingo K Mellinghoff, Martin J van den Bent, Deborah T Blumenthal et al. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Jun 4. Online ahead of print. Open reference URL https://web.pathway.md/studies/recCbGqKxtZxlof1U 2/2