Katherine B. Peters, MD, PhD, neuro-oncologist, Duke Cancer Center, discusses findings from the phase 3 INDIGO trial (NCT04164901) of vorasidenib in patients with recurrent or residual grade 2 glioma harboring an 

 mutation and how these results support the addition of vorasidenib to the treatment armamentarium. 

Dr Peters on the Efficacy of Vorasidenib in Glioma

-mutant diffuse glioma 1:1 to receive either the IDH1/2 inhibitor vorasidenib or placebo. The primary end point of this trial was progression-free survival (PFS), with time from randomization to the initiation of first subsequent therapy or death from any cause (TTNI) serving as a key secondary end point.

At a median follow-up of 14.0 months in the vorasidenib arm and 14.3 months in the placebo arm, the median PFS was 27.7 months with vorasidenib compared with 11.1 months with placebo, with a hazard ratio (HR) of 0.39. This level of statistically significant PFS benefit in this population has not been seen in over 20 years, Peters says.

In addition, the median TTNI was not reached in the vorasidenib arm compared with 17.8 months in the placebo arm, with an HR of 0.26. The 24-month TTNI rates were 83.4% and 27.0% with vorasidenib and placebo, respectively.

Dr Peters on the Future of Vorasidenib in Glioma

The INDIGO findings indicate that vorasidenib should be added to the 

-mutant glioma treatment paradigm as another therapeutic option for patients, caregivers, and clinicians to consider, Peters emphasizes. Vorasidenib slows disease progression and can thus be administered to patients upon the detection of measurable disease, Peters explains. Since this agent is IDH-directed, it specifically targets a common driver mutation in glioma, Peters notes.

In the future, vorasidenib may be investigated in combination with other therapies to provide additional effective treatment options for patients with glioma, Peters concludes.

Dr Peters reports consulting or advisory roles with Blue Earth Diagnostics, NuvOx Pharma, Ono Pharmaceutical, Sapience Therapeutics, and SERVIER; research funding from AbbVie, BioMimetix, Novocure, NuvOx Pharma, Sapience Therapeutics, SERVIER, and Varian Medical Systems; other relationships with Eisai Europe; and uncompensated relationships with

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Katherine B. Peters, MD, PhD, discusses findings from the phase 3 INDIGO trial of vorasidenib in patients with recurrent or residual grade 2 glioma harboring an IDH1 or IDH2 mutation and how these results support the addition of vorasidenib to the treatment armamentarium. 

Katherine B. Peters, MD, PhD

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Dr Peters on Vorasidenib in Residual or Recurrent IDH1/2-Mutant Glioma