Conference Proceedings

A phase Ib/II study of olutasidenib in patients with relapsed/refractory IDH1 mutant gliomas: Safety and efficacy as single agent and in combination with azacitidine.

Macarena Ines De La Fuente, Howard Colman, Mark Rosenthal, Brian Andrew Van Tine, Danijela Levaci, Tobias Walbert, Hui Kong Gan, Maria Vieito, Mohammed M Milhem, Kate Lipford, Sanjeev Forsyth, Sylvie Mireille Guichard, Yelena Mikhailov, Alexander Sedkov, Blythe Thomson, Patrick Francis Kelly, Varun Monga

JOURNAL OF CLINICAL ONCOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2020

Abstract

2505 Background: Isocitrate dehydrogenase 1 mutations (mIDH1) are present in >70% of patients with Grade II/III gliomas resulting in production and accumulation of (R)-2-hydroxyglutarate causing DNA hypermethylation and promoting tumorigenesis. Olutasidenib is an oral, potent, brain penetrant (Kpuu=0.4 in intact rodent), and selective inhibitor of mutated IDH1 protein. Methods: Patients (pts) with relapsed/refractory (R/R) mIDH1 gliomas received olutasidenib 150 mg BID, orally either as single agent (SA) or in combination (CO) with azacitidine in a dose confirmation phase Ib followed by efficacy evaluation phase II study (NCT: 03684811). Results: As of 31-Oct-2019, 29 pts with R/R mIDH1 gli..

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