publication date: Aug. 3, 2017

Hematologic Malignancies

Oral enasidenib demonstrates durable CRs in IDH2 mutant relapsed, refractory AML

Agios Pharmaceuticals Inc. published efficacy and safety data from the ongoing phase I/II dose-escalation and expansion study evaluating investigational oral Idhifa (enasidenib) in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation.

Idhifa, being developed in collaboration with Celgene Corp., is an investigational first-in-class, oral, targeted inhibitor of the mutant IDH2 enzyme.

Data in an oral session at the 22nd Congress of the European Hematology Association demonstrated an overall response rate of 37 percent, including a complete response rate of 20.1 percent in 214 patients with R/R AML who received enasidenib at 100 mg daily, which was the recommended starting dose in the expansion phases of the trial.

As of Oct. 14, 2016, a total of 345 patients with advanced hematologic malignances and an IDH2 mutation were enrolled into the phase I/II study, which includes three parts: a phase I dose escalation, a part 1 (phase I) expansion and a phase II expansion.

The phase I dose escalation study was designed to determine the maximum tolerated dose and recommended phase II dose, and to evaluate efficacy and safety of enasidenib (AG-221/CC-90007) in subjects with advanced hematologic malignancies with an IDH2 mutation.

The part 1 expansion further evaluated the safety, tolerability, and efficacy of enasidenib in subjects with R/R AML, untreated AML, myelodysplastic syndrome or other advanced hematologic malignancies with an IDH2 mutation.

Based on the clinical activity observed in R/R AML subjects, the phase II expansion was designed to assess efficacy of enasidenib at recommended 100 mg daily dose and to further evaluate safety in subjects with R/R AML and with IDH2 mutation.

The study was not designed or statistically powered to reach a conclusion on OS. … Continue reading CCL July 2017 – Oral enasidenib demonstrates durable CRs in IDH2 mutant relapsed, refractory AML

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