No treatment-related deaths were reported at the time of analysis. The most common treatment-related side effects: nausea, vomiting and febrile neutropenia. Several cases of asymptomatic QTc prolongation have been reported at the beginning of the study, but most are resolved after dose adjustment, and no grade 4 cases were reported. Management of other adverse events is also explored dose adjustments in this study.This interim analysis presented on the clinical response and safety in a subgroup of patients in the current phase 2 open single-arm, multicenter study conducted in the U.S. and Europe. Safety was reported on 62 patients and clinical response data was recorded on a group of 53 patients who met the efficacy evaluable (EE) criteria. Patients were included in the analysis is greater than or equal to 60 years and relapsed or refractory to first line chemotherapy (cohort 1, N = 25) or greater than or equal to 18 years and relapsed or refractory to second-line chemotherapy or transplantation (cohort 2, N = 37).
AC220 was developed in collaboration between Ambit Biosciences and Astellas Pharma Inc., is a novel, potent and highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor. The AC220 is currently being evaluated in a Phase 2 clinical trial as monotherapy for the treatment of adults and older adults with relapsed / refractory AML internal tandem duplication (INN) mutation in the FLT3 gene. AML is one of the most common types of blood in adults, with mutations in the gene for FLT3 ITD occurring in 25-30 % of patients with AML. FLT3 ITD mutations confer a poor prognosis, with early recurrence and lower survival after treatment with existing therapies, including chemotherapy and stem cell transplantation.
is a form of blood cancer. According to the American Cancer Society, about 13,000 were adults with newly diagnosed acute myeloid leukemia in 2009 in the United States, with about 9,000 expected to die from the disease this year. AML is generally a disease of the elderly and is rare before age 40. The average age of a patient with AML is 67 and the median survival for these patients is less than six months. The five-year survival rate for all AML patients less than 15 %. A report by Decision Resources, the U. AML will more than double by 2015.
The co-primary endpoint of the study are the composite rate of complete remission (CRC) and the rate of complete remission in 84 days. CRC is defined as the sum of complete remission (CR), complete remission with incomplete platelet recovery (CRP), and a complete remission with incomplete haematological recovery (CRI). Efficiency in the population assessed, there was a complete response in composite (CRC) at a rate of 45percent for all patients, and 41percent and 48percent of the cohort 1 and cohort 2, respectively, with most cases CCR represented by the IRC, without CR observed in the first 84 days. Major secondary endpoints of the study include the duration of remission, the response rate and overall survival. The median duration of response of patients who achieved a CRC was 12.1 weeks and 10.6 weeks in all patients and cohort 2, respectively, with patients censored at the time of transplantation. Cohort 1 has not yet reached a median duration of response. In addition to the observed rate of CRC, a further 25percent of patients evaluable for efficacy achieved a partial response (PR). The median survival of evaluable patients was 24.7 weeks efficacy and 24.1 weeks for all patients and a cohort, respectively. Cohort 2 has not reached a median survival, with 22 of the 31 patients alive at the time of analysis. More than one third of patients in the cohort 2 who had already failed chemotherapy for induction and rescue therapy in both the transition to the transplant.