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
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