Cell Therapeutics (CTI) has released updated on 18-month follow-up clinical data for phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).
The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed or refractory, aggressive nonHodgkin’s lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries.
Patients were randomised to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete remission (CR) or unconfirmed complete remission (uCR) rate, time to tumor progression, and overall survival. The study was conducted under a Special Protocol Assessment from the FDA and pixantrone has received fast track designation for this indication.
The most common adverse reactions reported for pixantrone-treated subjects were neutropenia, infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough.
James Bianco, chief executive officer of CTI, said: “We continue to be impressed by the durability of responses in the pixantrone treatment arm which seemed to improve during the study follow up period, compared to the standard chemotherapy recipients – whose responses and duration of response are largely unchanged from the initial assessment period.
“We are also encouraged by the increase in the overall survival estimates, especially among those patients whose histologic diagnosis was verified by independent pathologists where 40% of pixantrone recipients were alive, compared to 27% for standard chemotherapy at the 1 year landmark period. We plan to submit these updated safety and efficacy data to our NDA as part of the 120 Day update.”
Pixantrone has been accepted for standard review by the FDA, with fast track status with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.