Positive Phase III results for Servier's vorasidenib in glioma

French independent pharma major Servier presented new data for vorasidenib in IDH-mutant diffuse glioma at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showing that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee.

In the pivotal randomized, double-blind Phase III INDIGO clinical trial, vorasidenib demonstrated a remarkable improvement in progression-free survival (PFS) with a median of 27.7 months for vorasidenib versus 11.1 months for placebo in patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation. In a late-breaking new analysis, treatment with vorasidenib reduced tumor growth rate (TGR) and shrunk tumor volume, whereas continued growth in tumor volume was observed in patients randomized to the placebo arm.

Servier gained rights to vorasidenib when it acquired Agios Pharmaceuticals' oncology business for $2 billion in 2021. Vorasidenib was granted fast track designation by the US Food and Drug Administration (FDA) in March 2023.