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Agios leukemia drug shows positive response in phase 1 trial

Agios Pharmaceuticals Inc. leukemia drug ivosidenib showed promising responses in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-1 mutation in an ongoing phase 1 trial.

The data was presented at the annual meeting of the American Society of Hematology.

Primary analysis set data from the trial showed that 125 patients experienced a complete response and complete response with partial hematologic recovery rate of 30.4%, which is the main goal of the study. From these patients, 41.6% saw a reduction in their disease.

Median duration of response was 9.3 months for patients who achieved a complete response, 8.2 months for patients who achieved a complete response with partial hematologic recovery and 6.5 months for all patients who responded.

Data from 34 untreated acute myeloid leukemia patients not eligible for standard of care therapies demonstrated a 55.9% overall response rate and a complete response rate of 20.6%. The median duration of response was 9.2 months and median duration of complete response has not yet been reached.

In addition, data from 12 myelodysplastic syndrome patients demonstrated a 91.7% overall response rate and a complete response rate of 41.7%. Myelodysplastic syndromes are a group of disorders caused by poorly formed blood cells or ones that do not work properly.

Agios plans on filing a new drug application for ivosidenib with the U.S. Food and Drug Administration by the end of 2017.