Celgene Corp. and Agios Pharmaceuticals Inc. reported positive data from a phase 1 trial of IDHIFA in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation.
The trial met its primary endpoint with an overall response rate of 40.3% and a complete response rate of 19.3%. The median duration of response was 5.8 months for all patients who responded and 8.8 months for patients who achieved a complete response.
Median time to first response was 1.9 months, and median time to complete response was 3.8 months. The median overall survival for relapsed or refractory acute myeloid leukemia patients was 9.3 months.
The new drug application for IDHIFA is under priority review with the U.S. Food and Drug Administration for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation. Action on the application is expected Aug. 30.
Celgene and Agios plan to co-commercialize the drug in the U.S.