publication date: Aug. 4, 2015

Pracinostat/Vidaza Combination Shows Response in Phase II Leukemia Trial


Updated results from a phase II study of elderly patients with newly diagnosed acute myeloid leukemia showed that to date, in 50 patients treated with Pracinostat in combination with azacitidine (Vidaza), 27 patients achieved complete response, plus complete response with incomplete blood count recovery plus morphologic leukemia-free state, including 16 patients who achieved a CR.

The response rate from this study compares favorably with previous studies of azacitidine alone in this population. The trial data was presented at the European Hematology Association Annual Congress in Vienna.

Median overall survival has not yet been reached, with 32 patients still being followed (range, 6-15 months). Survival of patients with intermediate-risk cytogenetic abnormalities appears greater than that for patients with high-risk cytogenetics, though neither subset of patients has reached median survival. The 60-day mortality rate was 10 percent.

Pracinostat in combination with azacitidine was well tolerated in this population of elderly AML patients. The most common treatment-emergent adverse events included febrile neutropenia, thrombocytopenia, nausea and fatigue. AEs resulting in dose reductions were frequently due to disease under study. Nearly half of the patients (22 of 50) to date have received study drug beyond six months.

“The combination of Pracinostat and azacitidine continues to demonstrate compelling clinical activity in these elderly patients with newly diagnosed AML,” said Daniel Gold, president and CEO of the drug’s sponsor, MEI Pharma.

“While the overall survival trend in this study is encouraging, we believe that longer follow-up is needed to gain … Continue reading CCL July – Pracinostat/Vidaza Combination Shows Response in Phase II Leukemia Trial

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