Daniel A. Pollyea, MD
Ivosidenib induced an overall response rate (ORR) of 41.6% (95% CI, 32.9-50.8) in patients with IDH1
-positive relapsed/refractory acute myeloid leukemia (AML), according to a phase I dose-expansion study presented at the 2018 ASCO Annual Meeting and published simultaneously online in the New England Journal of Medicine
A once daily 500 mg dose of the IDH1 inhibitor demonstrated a median progression-free survival (PFS) of 8.2 months, a complete remission (CR) or CR with partial hematologic recovery (CRh) of 30.4% (95% CI, 22.5-39.3), and a CR rate of 21.6% (95% CI, 14.7-29.8). The primary efficacy endpoint of the study was CR of CRh, a protocol-defined endpoint.
“In this population of IDH
-positive relapsed/refractory AML patients, ivosidenib was able to achieve durable responses,” said lead author Daniel A. Pollyea, MD, assistant professor of Medicine at the University of Colorado Cancer Center and clinical director of Leukemia Services at the CU School of Medicine. “For the first time, we are able to tell you that the median overall survival for patients who achieved a CR is 18.8 months.”
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