ASCO: Servier's vorasidenib slows progression of glioma

French privately held pharma major Servier has presented results from the pivotal Phase III INDIGO clinical trial investigating vorasidenib, showing efficacy in the treatment of low-grade glioma, a difficult to treat form of brain cancer.

INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The primary endpoint, PFS per BIRC, was statistically significant and clinically meaningful in favor of the vorasidenib arm (HR, 0.39; 95% CI, 0.27 to 0.56; 1-sided P=0.000000067), median PFS for vorasidenib and placebo was 27.7 vs 11.1 months, respectively. TTNI was also statistically significant (HR, 0.26; 95% CI, 0.15 to 0.43; 1-sided P=0.000000019). Median TTNI was not reached for vorasidenib and 17.8 months for placebo.