Status Change

Servier's China real-world Voranigo study closes enrollment at 62 patients

The VICTORIA study moved to Active, not recruiting with a primary completion date pushed to April 2028, as it tests whether Voranigo's INDIGO-trial benefit holds in routine Chinese practice.

The VICTORIA real-world study of vorasidenib in IDH1/2-mutant Grade 2 astrocytoma or oligodendroglioma closed enrollment at 62 patients in China and moved to Active, not recruiting, while its primary completion date shifted from October 2026 to April 2028.

By AppliedXLJuly 21, 2026Trial NCT06969352

Executive Summary

A real-world study of an already-approved IDH1/2 inhibitor closed enrollment in China and shifted to Active, not recruiting, a routine progression for a study of this design.
The study tests whether the drug's tumor-growth-rate benefit, established in its pivotal randomized trial, holds up when used in typical clinical practice rather than under trial conditions.
The sponsor pushed the primary completion date out by roughly a year and a half, extending the window before the study's tumor-growth and progression-free survival readouts arrive.
The IDH1 inhibitor field carries several direct comparators in glioma, so this trial's value lies less in generating novel efficacy data than in confirming the drug's profile translates outside the registrational setting.

What happened

The VICTORIA study, a multicenter, retrospective-prospective real-world study of vorasidenib in patients with IDH1/2-mutant Grade 2 astrocytoma or oligodendroglioma, updated its registry status on July 21, 2026. Enrollment rose from an anticipated 60 to an actual 62 patients, and the study status moved from Not yet recruiting to Active, not recruiting. The primary completion date, originally set for October 2026, now reads April 2028, an 18-month extension recorded in the same update. NCT06969352+1

What the trial tests

VICTORIA is open-label and non-randomized, comparing patients treated with vorasidenib against an external control arm of untreated post-surgical patients drawn from Chinese hospital records, including West China Hospital and Beijing Tiantan Hospital. Its primary endpoint is tumor growth rate at six months after the index date, defined as percentage change in tumor volume from baseline; secondary endpoints include time to next intervention and real-world progression-free survival assessed under modified RANO-LGG criteria over 30 months. The design is not registrational: it is built to observe how the drug performs in routine practice, not to support a new approval. NCT06969352

The precedent it draws on

Vorasidenib, marketed as Voranigo, is approved for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma carrying a susceptible IDH1 or IDH2 mutation following surgery. That approval rests on the randomized INDIGO trial (NCT04164901), sponsored by Servier, which VICTORIA's own readthrough data ties to this study as its most relevant same-drug precedent. VICTORIA's job is to show that the tumor-growth and progression-free survival pattern behind that approval reproduces in a Chinese real-world population, the bar this kind of bridging study must clear rather than a fresh superiority test.

Competitive landscape

IDH1 inhibition in glioma is not sparse: Servier's own Phase 3 vorasidenib trial in Asian patients with residual or recurrent Grade 2 glioma (NCT06780930) is running alongside Nuvation Bio's safusidenib, Rigel Pharmaceuticals' olutasidenib, and Daiichi Sankyo's safusidenib erbumine, all direct comparators sharing the IDH1 target and small-molecule modality in glioma. Against that field, VICTORIA does not need to differentiate on mechanism; its value is confirming the drug's established profile holds outside the controlled trial population that produced it.

Operational read

The enrollment increase from 60 to 62 patients is a routine adjustment, not a shortfall, and the status move to Active, not recruiting follows directly from enrollment completion. The one substantive change is the completion-date shift, which cumulatively pushed the primary completion date back 548 days from its original schedule. That extension delays when the tumor-growth-rate and progression-free survival data will be available, without altering what the study is designed to measure. NCT06969352

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.