Phase III INDIGO clinical trial of AG 881 meets primary and secondary endpoints in glioma.- Servier
Servier announced that the Phase III INDIGO clinical trial investigating AG 881 (vorasidenib) in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis were both statistically significant and clinically meaningful.
The interim analysis, which was prespecified in the design of the INDIGO trial, demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and time to next intervention in patients randomized to vorasidenib monotherapy compared to patients randomized to placebo. Patients enrolled in the INDIGO study had residual or recurrent grade 2 oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation and had undergone surgery as their only treatment for glioma prior to study enrollment. The safety profile of vorasidenib in monotherapy was consistent with previously published data. The Phase III INDIGO trial results will be presented at an upcoming medical meeting.
Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule. Servier is working to determine filing timelines and adapt the vorasidenib supply capacity. INDIGO is a phase III, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. (NCT04164901).
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