NEW YORK (Reuters) - Cephalon Inc’s experimental cancer drug Treanda appeared to be effective in patients whose non-Hodgkin’s lymphoma (NHL) had progressed during or following treatment with Rituxan in late-stage study, the company and researchers said on Saturday.
Treanda, also known as bendamustine, induced a high rate of response in the 100-patient study, according to data presented at the American Society of Hematology annual meeting in Atlanta.
The primary goal of the study was for Treanda to achieve a response in at least 60 percent of patients, and a duration of response of at least six months, the company said.
In this pivotal phase 3 study, 75 percent of patients responded to the drug with a median duration of response of 9.2 months. Both were considered to be statistically significant, researchers said.
Of the 75 patients who responded, 14 had a complete response and three had an unconfirmed complete response.
“The high response rate in this study suggest that bendamustine could offer substantial periods of remission to patients with indolent (slow growing) NHL whose cancer is progressing after treatment with rituximab,” Brad Kahl, the trial’s lead investigator, said in a statement using the generic name for Rituxan.
“Because many patients with NHL eventually become resistant to treatment with rituximab and other therapies, new treatments are always required,” Kahl said.
Rituxan is a non-Hodgkin’s lymphoma treatment sold by Genentech Inc and Biogen Idec Inc.
Cephalon has said it intends to use this study in its submission seeking U.S. approval of Treanda in this patient population. It expects to send the data seeking approval to the Food and Drug Administration by the end of the year.
An estimated 30,000 people in the United States will be diagnosed in 2007 with indolent NHL, a serious cancer of the lymphatic system in which patients are prone to relapse after treatment, according to the National Cancer Institute.
The data from the phase 3 study — typically the final stage of human testing before a medicine is submitted for approval — confirmed results seen in an earlier phase 2 study, the company said.
“In a population of patients who really do not have a standard of care at the moment, we demonstrated a very high response rate, and those responses are durable,” Charles Morris, Cephalon’s vice president of clinical research for oncology, said in a telephone interview from Atlanta.
“It looks like a very effective therapy in this group of patients,” Morris said.
The most common serious side effect seen with the Cephalon drug, which is administered intravenously over 60 minutes, was low white blood cell count with fever and pneumonia.
Reporting by Bill Berkrot, editing by Richard Chang