Treanda bendamustine: Final Phase III data

Final data from an open-label, German Phase III trial in 513 patients showed that Treanda plus rituximab met the primary endpoint of significantly increased median PFS vs. CHOP-R chemotherapy (cyclophosphamide, vincristine, prednisone and rituximab) (54.8 vs. 34.8 months, p=0.0002). Treanda plus rituximab also significantly increased median EFS vs. CHOP-R chemotherapy (54 vs. 31 months, p=0.0002). The study was powered to show non-inferiority on the EFS endpoint, defined as <10% difference between the regimens after 3 years. Time to next treatment was 40.7 months for CHOP-R, but was not reached for Treanda plus rituximab. Data will be presented at the American Society of Hematology meeting in New Orleans in December. The companies previously reported that Treanda plus rituximab produced an overall response rate (ORR) and complete remission rate of 94% and 41%, respectively, vs. 93% and 33% for CHOP-R chemotherapy (see BioCentury, Dec. 15, 2008). ...