New data shows Servier’s vorasidenib reduced tumour growth in a Phase III study in patients with IDH-mutant diffuse glioma.
In the newest analysis of the Phase III INDIGO trial (NCT04164901) vorasidenib demonstrated reduced tumour growth rate (TGR) and shrunk tumour volume, as measured by an independent radiology committee, while patients in the placebo arm saw continued growth in tumour volume.
Dana Farber Cancer Institute neuro-oncology division chief Dr Patrick Wen said: “These data from the INDIGO study offer the first prospective volumetric dataset in IDH-mutant gliomas and provide robust evidence that treatment with vorasidenib not only delays or prevents tumour growth but also lead to tumour shrinkage.”
The placebo-controlled, randomised, double-blinded study evaluated vorasidenib in patients with grade 2 glioma who have undergone surgery as their only treatment.
Out of the total 331 patients enrolled during the second planned interim analysis, 168 received 40mg of vorasidenib daily and 163 received placebo in 28-day cycles.
New data continues to be positive
Tumour volume in vorasidenib-treated patients decreased by a mean of 2.5% every six months, while it increased by a mean of 13.9% in patients receiving placebo.
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New data showed that vorasidenib preserved of quality of life, and stabled neurocognitive function and seizure control. In addition, translational data demonstrated vorasidenib’s efficacy across IDH-mutant diffuse gliomas with various additional mutations.
In the Phase III data released in June 2023, vorasidenib demonstrated improvement in progression-free survival (PFS) with a median of 27.7 months compared to 11.1 months for placebo in patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation.
Vorasidenib was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) in June 2020. Servier plans to submit a new drug application (NDA) for vorasidenib to the FDA by the end of 2023 and the European Medicines Agency (EMA) in early 2024.
In April 2021, Servier acquired vorasidenib as part of a $1.8bn business acquisition of Agios Pharmaceuticals.