BOSTON, Massachusetts, May 31, 2026
Servier has announced extended follow-up results from the pivotal Phase 3 INDIGO trial, demonstrating that VORANIGO® (vorasidenib) continues to provide durable and sustained clinical benefits for patients with Grade 2 IDH-mutant glioma more than three years after treatment initiation. Presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the updated findings reinforce VORANIGO’s role as a groundbreaking targeted therapy for patients with residual or recurrent glioma following surgery. The long-term analysis revealed significant improvements in progression-free survival (PFS), prolonged delays in the need for additional treatment interventions, reduced seizure rates, and a consistent safety profile. These results further strengthen the growing body of evidence supporting long-term IDH inhibition as an effective strategy for managing low-grade gliomas and improving outcomes for patients facing chronic neurological disease progression.
INDIGO Trial Confirms Long-Term Disease Control
The updated Phase 3 INDIGO analysis included more than three years of follow-up data, with a median follow-up duration of 41.6 months, making it the largest and most mature dataset available for patients with IDH1/2-mutant Grade 2 glioma. Researchers reported that patients treated with VORANIGO achieved a remarkable median progression-free survival of 44.1 months, demonstrating sustained control of tumor growth over an extended period.
The study also showed that the median time to next intervention was not yet reached, highlighting the therapy’s ability to delay the need for additional treatments such as chemotherapy, radiation therapy, or further surgery. Importantly, only 23.8% of patients required subsequent intervention, emphasizing the long-lasting therapeutic effect of VORANIGO. Investigators also observed an objective response rate of 20.8%, with response rates continuing to improve over time, while an additional 72.6% of patients maintained stable disease, reflecting broad and durable disease management across the study population. These findings reinforce the value of targeted molecular therapies in managing brain tumors characterized by specific genetic mutations.
Significant Reduction in Seizures Improves Patient Outcomes
Advertisement
Beyond delaying disease progression, VORANIGO demonstrated meaningful benefits in controlling one of the most debilitating symptoms experienced by glioma patients—seizures. An exploratory analysis presented at ASCO 2026 showed a 72% reduction in the rate of on-treatment seizures among patients receiving VORANIGO. Seizure control represents a critically important treatment goal for glioma patients because recurrent seizures can significantly impact quality of life, cognitive function, daily activities, and overall neurological health.
The analysis revealed particularly strong benefits among patients with oligodendroglioma, who experienced notably lower seizure rates during long-term treatment. These findings suggest that VORANIGO may offer clinical benefits extending beyond traditional tumor measurements by helping patients maintain neurological stability and preserve daily functioning. As seizure burden remains one of the most challenging aspects of glioma management, the demonstrated long-term seizure reduction provides additional support for incorporating targeted IDH inhibition into routine clinical practice.
Favorable Safety Profile Supports Long-Term Treatment Strategy
Long-term safety outcomes remained consistent with previously reported INDIGO data, providing reassurance regarding extended use of VORANIGO. The therapy was generally well tolerated, with most adverse events classified as low grade and manageable through routine clinical monitoring. The most frequently reported serious treatment-emergent adverse events involved elevations in liver enzymes, including alanine aminotransferase and aspartate aminotransferase levels, along with occasional seizure-related events. Importantly, no new safety signals were identified, and fewer than 5% of patients discontinued treatment due to adverse events.
The findings are particularly important because patients with Grade 2 glioma often face a prolonged disease course requiring years of disease management. Historically, many patients were monitored under a “watch-and-wait” approach because of limited targeted treatment options. The latest INDIGO results demonstrate that VORANIGO can provide durable disease control while maintaining a manageable safety profile over several years of treatment. As the first targeted therapy specifically developed for IDH-mutant glioma, VORANIGO continues to redefine treatment expectations and offers new hope for patients seeking effective long-term management of this challenging brain cancer.
Source: Servier press release
