Voranigo Continues to Benefit Patients With Grade 2 IDH-Mutated Glioma

Longer-term results show that Voranigo (vorasidenib) continues to benefit people with grade 2 glioma that has an IDH1 or IDH2 mutation, according to a news release from Servier.

These updated Phase 3 INDIGO trial data, now published in The Lancet Oncology, suggest that the treatment may help control the disease after surgery for those who can safely delay chemotherapy and radiation. The updated analysis includes six more months of data from when patients and doctors did not know who was receiving Voranigo or a placebo. These positive findings confirm and strengthen what the INDIGO study had already shown about the treatment’s benefit.

"These longer-term results from the INDIGO trial build upon VORANIGO's previously demonstrated clinical benefits and demonstrate reductions in tumor volume and seizure frequency in patients with IDH-mutated gliomas," Becky Martin, chief of medical, Servier Pharmaceuticals, said in the news release. "One year after the FDA approval of Voranigo, we're immensely proud to have delivered this first-of-its-kind targeted therapy to thousands of patients living with IDH-mutated glioma, offering them clinically meaningful and durable treatment benefits supported by more than a decade of research."

As of March 7, 2023, patients in the study had been followed for a median of 20.1 months. Patients taking Voranigo continued to have longer time without their tumor growing compared with those taking a placebo. This measure is called progression-free survival and was the main goal of the trial. Imaging showed that the cancer grew in 32% of patients taking Voranigo and 64% of those taking a placebo. These results were consistent across all groups studied.

Patients taking Voranigo also went longer before needing another treatment, showing that disease control lasted over time.

In addition, Voranigo slowed tumor growth and reduced seizures compared with placebo, without hurting quality of life or thinking abilities. Among patients who had at least one seizure, those taking Voranigo had 18.2 seizures per person-year compared with 51.2 seizures per person-year for those taking a placebo.

Voranigo’s safety remained similar to what has been seen before, as per the release. The most common serious side effects were increased alanine aminotransferase (10%), increased aspartate aminotransferase (5%), seizures (4%) and increased gamma-glutamyltransferase (3%). Fewer than 5% of people stopped treatment because of a side effect and no deaths were linked to Voranigo.

"For decades, patients with Grade 2 IDH-mutated gliomas had limited treatment options. While surgery was often the first line treatment option for glioma, total resection was rarely achievable because tumors continue to grow and infiltrate the brain even after surgery," Dr. Timothy Cloughesy, David Geffen School of Medicine, Department of Neurology, University of California, Los Angeles, investigator for the INDIGO trial, said in the news release. "The longer-term data from the INDIGO trial demonstrate that targeted IDH inhibition can fundamentally alter the growth trajectory of certain gliomas, leading to gradual tumor shrinkage."

Trial Design

INDIGO is a global Phase 3 study designed to support approval of Voranigo. It is a randomized, double-blind, placebo-controlled trial, meaning participants were randomly assigned to receive either the study drug or a placebo, and neither they nor their doctors knew which one they were getting. The trial included people with residual or recurrent grade 2 glioma with an IDH1 or IDH2 mutation who had only received surgery so far.

As of March 7, 2023, 331 people were enrolled worldwide. They received either Voranigo 40 milligrams once a day (168 people) or a placebo (163 people), taken in 28-day cycles. Of everyone in the trial, 172 had oligodendroglioma (88 received Voranigo and 84 received placebo) and 159 had astrocytoma (80 received Voranigo and 79 received placebo).

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Reference:

"Servier Announces Positive Findings from Longer-Term Analysis of the Phase 3 INDIGO Trial Showing Continued Durable Treatment Effect of VORANIGO® (vorasidenib) Published in The Lancet Oncology," news release; https://servier.mediaroom.com/2025-11-03-Servier-Announces-Positive-Findings-from-Longer-Term-Analysis-of-the-Phase-3-INDIGO-Trial-Showing-Continued-Durable-Treatment-Effect-of-VORANIGO-R-vorasidenib-Published-in-The-Lancet-Oncology