Servier announced that vorasidenib has met the primary endpoint and a key secondary endpoint in the Phase 3 INDIGO clinical trial in patients with residual or recurrent grade 2 glioma.

The French oncology company studied the investigational drug in glioma patients with an isocitrate dehydrogenase 1 or 2 (IDH1/2) mutation and who have undergone surgery as their only treatment.

Vorasidenib is an oral, selective, brain-penetrant dual inhibitor of mutant IDH1/2 enzymes.

In the late-stage trial featuring 331 patients, the drug candidate met the primary endpoint of progression free survival (PFS) per the blinded independent review committee (BIRC). It also achieved its key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis.

Published in the New England Journal of Medicine, the data from the trial revealed that the primary endpoint was statistically significant and clinically meaningful in the vorasidenib arm. The median PFS for the investigational drug and placebo was 27.7 and 11.1 months, respectively.

Servier said that TTNI was also statistically significant.

The company said that the median TTNI was not reached for vorasidenib and for placebo it was 17.8 months.

Servier clinical development VP Susan Pandya said: “The overwhelmingly positive INDIGO results convincingly demonstrate the impact of targeting IDH mutations early in cancer biology where a monotherapy approach can lead to a profoundly meaningful outcome for patients with recurrent or residual IDH-mutant grade 2 gliomas.

“IDH mutations are disease defining alterations in IDH-mutant diffuse gliomas and these pivotal data coupled with vorasidenib’s especially high penetration of the blood-brain barrier, offer opportunities to evolve the treatment landscape for patients living with this malignancy.

“We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma.”

INDIGO is a registration-enabling global, randomised, double-blinded placebo-controlled study.

The safety profile for vorasidenib was well tolerated and consistent with findings from the Phase 1 study.

Vorasidenib secured fast track designation from the US Food & Drug Administration (FDA) in March 2023. The oncology company is also planning to submit a new drug application (NDA) for vorasidenib to the FDA.