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news.MEI Pharma (MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced updated results from a Phase II study of its investigational drug candidate Pracinostat in combination with azacitidine (marketed as Vidaza) in elderly patients with newly diagnosed acute myeloid leukemia (AML).
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Data from 50 patients treated at 15 centers are being presented at the European Hematology Association (EHA) Annual Congress in Vienna. A copy of the poster, entitled "Updated Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia," is now available at www.meipharma.com.
To date, 27 of 50 patients (54%) have achieved the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS), including 16 patients (32%) who achieved a CR.
The response rate from this study compares favorably with previous studies of azacitidine alone in this population1. Most responses occur within the first two cycles and continue to improve with ongoing therapy.
Median overall survival has not yet been reached in the study, with 32 patients (64%) 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, often used as a benchmark in AML clinical studies, was 10% (5 of 50).
Pracinostat in combination with azacitidine was well tolerated in this population of elderly AML patients. The most common treatment-emergent adverse events (AEs) 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, reflecting long-term tolerability.
"The combination of Pracinostat and azacitidine continues to demonstrate compelling clinical activity in these elderly patients with newly diagnosed AML," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma.
"While the overall survival trend in this study is encouraging, we believe that longer follow-up is needed to gain an accurate survival estimate. Ultimately, this survival estimate will be critical in determining the development path forward for this combination. We look forward to providing an update when these data mature, which we expect to occur later this year."