Servier announced that the Phase 3 INDIGO clinical trial investigating 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).
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The results of the prespecified interim analysis were both statistically significant and clinically meaningful.
"Therapeutic progress in the low-grade glioma space has been stagnant for decades. The results of the Phase 3 INDIGO trial, meeting both the primary endpoint of progression-free survival and the key secondary endpoint of time to next intervention, presents an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially delivering the first targeted therapy," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier.
"We are grateful to the patients, caregivers, investigators and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial."
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.
INDIGO is a phase 3, 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).
Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 WHO classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas.
These diffuse gliomas are the most common primary malignant brain tumors in adults.
The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. ■
A very strong low pressure system currently just offshore of San Francisco Bay will continue to bring high winds, heavy rain, and heavy mountain snow for California and adjacent areas of the Southwest through tonight and Wednesday as the latest in a series of atmospheric rivers impacts the West.