Updated results from phase III EXTEND clinical trial of pixantrone released
September 02, 2015
Results presented also included a patient subgroup analysis demonstrating that complete response (CR), partial response (PR) and PFS were robust irrespective of risk factors or prior therapy. Pixantrone also provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients.
Despite 50% of patients exceeding cumulative lifetime anthracycline limits (501 - 900 mg/m2), only two cases of congestive heart failure on independent cardiologist assessment were attributed to pixantrone, occurring at lowest drug exposure (<501mg/m2). The follow-up period for the study is ongoing.
"We are pleased that the PIX 301 EXTEND trial of pixantrone not only met its study objective but continues to demonstrate clinical benefit in the follow up period across patient demographics, and risk factors," said James A. Bianco, M.D., Chief Executive Officer of CTI. "We continue to work expeditiously with the FDA as we progress pixantrone through regulatory review to potential approval and commercialization."
The most common (incidence greater than or equal to 10%) grade 3-4 adverse events reported for pixantrone-treated subjects across the studies were neutropenia and leucopenia. Other common adverse events (any grade) included infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough. Although the grade 3/4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (6/68 or 8.8% vs. 3/67 or 4.5%).SOURCE Cell Therapeutics, Inc.