Servier has reported that the Phase III INDIGO trial of vorasidenib in patients with recurrent or residual grade 2 isocitrate dehydrogenase (IDH) mutant diffuse glioma has met both the primary and key secondary endpoints.
The placebo-controlled, randomised, global, double-blinded, registration-enabling study of vorasidenib has evaluated grade 2 glioma patients 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 placebo in 28-day cycles.
Median time from the last surgery until randomisation was 2.5 years on patients in vorasidenib arm vs 2.2 years on those in the placebo arm.
The primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) was statistically significant and clinically meaningful in favour of the vorasidenib arm and, median PFS for vorasidenib and placebo was 27.7 vs 11.1 months, respectively.
The study also met key secondary endpoint of time to next intervention at the prespecified second interim analysis.
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Servier Cancer Metabolism Global Development Oncology & Immuno-Oncology head and Clinical Development vice-president 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.”