TREANDA induces durable responses in indolent B-cell non-Hodgkin's lymphoma patients

Cephalon, Inc. (Nasdaq: CEPH) today announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab. Results of this study, which supported the FDA approval of TREANDA in this patient population in October 2008, were published online yesterday and will also appear in the print edition at a later date. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed this year with indolent NHL, a slow growing but serious cancer of the lymphatic system.

"The findings from this study confirm and expand upon previous investigations with bendamustine. Bendamustine provides physicians and patients with another valuable treatment option for recurring indolent B-cell NHL, a patient population that continues to grow," said Brad Kahl, M.D., Associate Professor, Director Lymphoma Service, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, and the lead investigator of this study.

In this multicenter, open-label, single-arm study, 100 patients received TREANDA intravenously at a dose of 120 mg per meter squared over 60 minutes on days one and two every 21 days for up to eight cycles. There were two primary endpoints in the study: the overall response rate (ORR) defined as the percentage of patients who responded to treatment, and the duration of response. In the published results, 75 percent of patients had a response to treatment with TREANDA, including 14 percent who had a complete response and three percent who had an unconfirmed complete response. The patient response to treatment lasted a median of 9.2 months. The most common adverse events in this study included myelosuppression, nausea, infection, fatigue, diarrhea, vomiting and fever; serious adverse events included febrile neutropenia and pneumonia.