Vorasidenib monotherapy extends PFS for certain patients with low-grade glioma
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Vorasidenib conferred statistically significant and clinically meaningful improvements in PFS and time to next intervention for patients with residual or recurrent IDH-mutant low-grade glioma, according to the agent’s manufacturer.
The randomized, double-blind phase 3 INDIGO study compared the efficacy of vorasidenib (Servier) with placebo among individuals with residual or recurrent grade 2 oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation who had previously only undergone surgery.
Results of a prespecified interim analysis showed the trial met the primary endpoint of PFS and secondary endpoint of time to next intervention. In addition, vorasidenib has a safety profile consistent with data reported previously.
“Therapeutic progress in the low-grade glioma space has been stagnant for decades,” Susan Pandya, MD, vice president of clinical development and head of cancer metabolism global development oncology and immuno-oncology for Servier, said in a press release. “The results of the phase 3 INDIGO trial ... [present] an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially delivering the first targeted therapy.”
The FDA has granted vorasidenib fast track designation, according to the press release.
Data from the INDIGO trial will be presented at a future medical meeting.
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