Servier Announced New Data from P-III study (INDIGO) for Glioma Patients

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Servier Announced New Data from P-III study (INDIGO) for Glioma Patients


  • The P-III (INDIGO) trial evaluating the efficacy of vorasidenib (40mg; QD) vs PBO in patients with residual or recurrent grade 2 glioma with an IDH1 or IDH2 mutation (n=340) in 1:1 ratio 
  • The result depicted a reduction in the tumor volume by a mean of 2.5% at every 6mos. vs an increase in Tumor volume by 13.9%, it showed a median PFS of 27.7 vs 11.1mos, and furthermore 61% reduction in tumor growth. These results were published in NEJM & presented at the annual meeting of the SNO
  • Servier is ready to file NDA by YE based on these data. Vorasidenib, a brain-penetrant inhibitor of mutant IDH1 and IDH2 proteins had also received the FDA’s breakthrough therapy designation for the same indication

Ref: Biospace | Image: Servier

Related Post:- Servier Reports P-III Trial (INDIGO) Results of Vorasidenib for IDH-Mutant Low-Grade Glioma

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Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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