INDIGO
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
56.0% male
N = 331
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
11.1 months
27.7 months
20.8 months
13.8 months
6.9 months
0.0 months
Vorasidenib
Placebo
Significant
increase ▲
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 Aug 17;389(7):589-601.
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