Cephalon presents positive Treanda trial results

The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile. The study evaluated the efficacy and safety of single-agent Treanda in 100 patients with relapsed, rituximab-refractory non-Hodgkin’s lymphoma (NHL). The overall response rate, as assessed by an independent radiological committee, was 75% (p<0.0001) and the median duration of response was 40 weeks (or 9.2 months). The overall response rate includes the percent of patients in the trial who had a complete, unconfirmed complete or partial response to treatment. The most common side effects included nausea, fatigue, neutropenia, diarrhea and vomiting. The company anticipates that the results of this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007. Dr Lesley Russell, executive vice president, worldwide medical and regulatory operations "We are encouraged that these results replicate those seen in our Phase II study, confirming the substantial efficacy in this difficult to treat population. Based on these positive results, we are on track to file a new drug application in the Q4 for Treanda in patients with indolent NHL who have failed treatment with rituximab."