• Clinically meaningful achievement of primary and secondary endpoints is first major advance in treatment of low-grade glioma in more than 20 years
  
  
• Endpoints met in a prespecified interim analysis
  
  
• vorasidenib granted fast track designation by U.S. Food & Drug Administration (FDA)

"Therapeutic progress in the low-grade glioma space has been stagnant for decades. The results of the Phase 3 INDIGO trial, meeting both the primary endpoint of progression-free survival and the key secondary endpoint of time to next intervention, presents an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially delivering the first targeted therapy," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "We are grateful to the patients, caregivers, investigators and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial."

The interim analysis, which was prespecified in the design of the INDIGO trial, demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and time to next intervention in patients randomized to vorasidenib monotherapy compared to patients randomized to placebo. Patients enrolled in the INDIGO study had residual or recurrent grade 2 oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation and had undergone surgery as their only treatment for glioma prior to study enrollment. The safety profile of vorasidenib in monotherapy was consistent with previously published data.

"This potential therapeutic breakthrough is yet another concrete proof-point of the success of our oncology strategy, which aims to focus our science on difficult and hard-to-treat cancers such as those where an IDH mutation is present," said Patrick Therasse, M.D. PhD, Vice-President and  Head, Late Stage and Life Cycle Management Oncology & Immuno-oncology Therapeutic Area, Servier. "The results from the Phase 3 INDIGO trial offer patients with IDH mutant low-grade glioma potential hope for a new treatment option for the first time in more than 20 years."

The Phase 3 INDIGO trial results will be presented at an upcoming medical meeting.

Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule. Servier is working to determine filing timelines and adapt the vorasidenib supply capacity.