Servier, a France-based company involved in innovative oncology therapies, announced on Sunday its results from the pivotal Phase three INDIGO clinical trial assessing vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes, in subjects with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma that have only been treated with surgery.

INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis.

The primary endpoint, PFS per BIRC was in favour of the vorasidenib arm (HR, 0.39; 95% CI, 0.27 to 0.56; 1-sided P=0.000000067), median PFS for vorasidenib and placebo was 27.7 compared to 11.1 months, respectively. TTNI was also statistically significant (HR, 0.26; 95% CI, 0.15 to 0.43; 1-sided P=0.000000019) while Median TTNI was not reached for the product and 17.8 months for placebo.

The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.

Vorasidenib, received fast track designation from the US Food & Drug Administration (FDA) in March 2023. The company is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.