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ARTICLE | Clinical News

Tosedostat: Interim Phase II data

December 23, 2013 8:00 AM UTC

Interim data from the first cohort of an open-label, U.S. Phase II trial in 26 patients ages >=60 years with newly diagnosed AML or high-risk MDS showed that once-daily 120 mg oral tosedostat on days 1-21 of a 35-day cycle plus either cytarabine or decitabine on days 1-5 led to a 4-month OS rate of 81%. There were 10 complete remissions and 4 complete remissions with incomplete blood count recovery. Ten patients subsequently received a hematopoietic stem cell transplantation (HSCT). There were 3 deaths from sepsis on subsequent salvage protocols, 1 death from splenic infarct in a patient with a history of myeloproliferative disorder and 1 death due to an unknown cause. There were no grade 3/4 non-hematologic toxicities requiring withdrawal from the trial. The trial was sponsored by the Fred Hutchinson Cancer Research Center and the University of Washington Cancer Consortium. Data were presented at the American Society of Hematology meeting in New Orleans. ...