Cephalon drug works in non-Hodgkin's lymphoma: study

Cephalon drug works in non-Hodgkin's lymphoma: study
NEW YORK (Reuters) - Cephalon Inc's experimental cancerdrug Treanda appeared to be effective in patients whosenon-Hodgkin's lymphoma (NHL) had progressed during or followingtreatment with Rituxan in late-stage study, the company andresearchers said on Saturday.
Treanda, also known as bendamustine, induced a high rate ofresponse in the 100-patient study, according to data presentedat the American Society of Hematology annual meeting inAtlanta.
The primary goal of the study was for Treanda to achieve aresponse in at least 60 percent of patients, and a duration ofresponse of at least six months, the company said.
In this pivotal phase 3 study, 75 percent of patientsresponded to the drug with a median duration of response of 9.2months. Both were considered to be statistically significant,researchers said.
Of the 75 patients who responded, 14 had a completeresponse and three had an unconfirmed complete response.
"The high response rate in this study suggest thatbendamustine could offer substantial periods of remission topatients with indolent (slow growing) NHL whose cancer isprogressing after treatment with rituximab," Brad Kahl, thetrial's lead investigator, said in a statement using thegeneric name for Rituxan.
"Because many patients with NHL eventually become resistantto treatment with rituximab and other therapies, new treatmentsare always required," Kahl said.
Rituxan is a non-Hodgkin's lymphoma treatment sold byGenentech Inc and Biogen Idec Inc.
Cephalon has said it intends to use this study in itssubmission seeking U.S. approval of Treanda in this patientpopulation. It expects to send the data seeking approval to theFood and Drug Administration by the end of the year.
An estimated 30,000 people in the United States will bediagnosed in 2007 with indolent NHL, a serious cancer of thelymphatic system in which patients are prone to relapse aftertreatment, according to the National Cancer Institute.
The data from the phase 3 study -- typically the finalstage of human testing before a medicine is submitted forapproval -- confirmed results seen in an earlier phase 2 study,the company said.
"In a population of patients who really do not have astandard of care at the moment, we demonstrated a very highresponse rate, and those responses are durable," CharlesMorris, Cephalon's vice president of clinical research foroncology, said in a telephone interview from Atlanta.
"It looks like a very effective therapy in this group ofpatients," Morris said.
The most common serious side effect seen with the Cephalondrug, which is administered intravenously over 60 minutes, waslow white blood cell count with fever and pneumonia.
(Reporting by Bill Berkrot, editing by Richard Chang)