Cephalon, Inc, announced positive results from a phase III clinical trial of bendamustine (Treanda) in patients with indolent non-Hodgkin's lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab (Rituxan). The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.
The phase III, multicenter, single-arm study evaluated the efficacy and safety of single-agent bendamustine in 100 patients with relapsed, rituximab-refractory NHL. The overall response rate, as assessed by an independent radiologic committee, was 75% (P < .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.
"We are encouraged that these results replicate those seen in our phase II study, confirming the substantial efficacy in this difficult to treat population," said Dr. Lesley Russell, executive vice president, Worldwide Medical and Regulatory Operations. "Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab."
The protocol for the NHL pivotal trial received special protocol assessment (SPA) approval from the US Food and Drug Administration (FDA) in February 2006. The SPA process allows for FDA evaluation of a clinical trial protocol, which will be used as the basis of an efficacy claim to support a New Drug Application (NDA). In September 2007, Cephalon submitted an NDA requesting approval of bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL), for which the FDA has granted orphan drug status.