Cell Therapeutics, Inc. (CTI), a biopharmaceutical company, has announced that, based on preliminary encouraging confirmed and unconfirmed complete response (CR/uCR) rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma (NHL), treated in its randomized phase III trial of pixantrone, the Data Monitoring Committee recommended that the study continue. The company plans to conduct a second interim analysis early next year.
"Consistent with the recent guidance from the US Food and Drug Administration's Deputy Commissioner regarding adaptive trial design, this interim analysis allowed us to determine if the primary endpoint of the study is tracking within our initial CR rate projections or substantially higher, than what was anticipated when the study was powered and initiated," stated Scott C. Stromatt, M.D., CTI's executive vice president of Clinical Development and Regulatory Affairs. "Given the preliminary results reported by the independent Data Monitoring Committee, we believe another analysis of the primary endpoint after 100 patients have completed therapy is both warranted and ethical."
The extend clinical trial is a phase III trial for patients with relapsed, aggressive non-Hodgkin's lymphoma who have received two or more prior therapies. The trial is being conducted in 130 sites in 17 countries. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population. The trial is designed to examine the complete response (CR) or unconfirmed complete response (uCR) rate, time to tumour progression, and overall survival. The study was powered based on a CR rate assumption of less than 5 percent for the control arm and a 10 percent improvement in CR rate for the pixantrone arm. The study is being conducted under a Special Protocol Assessment from the US Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication.
Pixantrone is an investigational agent under development for the potential treatment of various haematological malignancies, solid tumours and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumour types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplified administration compared to the currently marketed anthracyclines.