Cephalon's Treanda tops CHOP chemo in NHL - study

By Bill Berkrot

NEW YORK, Dec 7 (Reuters) - Cephalon Inc's Treanda was significantly more effective and far less toxic than a standard CHOP chemotherapy regimen as an initial treatment for non-Hodgkin's lymphoma, according to data from a clinical trial presented on Monday.

Both treatments were tested in combination with Rituxan, a non-Hodgkin's lymphoma (NHL) drug sold by Roche Holding and Biogen Idec Inc, in patients with follicular, indolent and mantle cell lymphomas -- all forms of NHL.

Based on their findings, researchers said Treanda and Rituxan (rituximab) could become the new first treatment option for the slowly developing forms of cancer, replacing Rituxan and CHOP -- an acromym for a regimen of four chemotherapy drugs.

The data, unveiled at the American Society of Hematology meeting in New Orleans, could help expand sales of the relatively new Cephalon drug, which is currently approved as a second-line treatment for NHL, as well as for chronic lymphocytic leukemia.

The primary goal of the 513-patient, four-and-a-half-year study was progression-free survival, or the time it takes for the disease to worsen.

Patients given Treanda, a form of chemotherapy known chemically as bendamustine, had a median progression-free survival of 54.9 months compared with 34.8 months with CHOP, which researchers called statistically highly significant.

There was also a statistically significant advantage in complete response, with 39.6 percent of Treanda patients achieving remission versus 30 percent with CHOP.

'I think bendamustine plus Rituxan does have the potential to become the treatment of first choice in these diseases -- follicular lymphoma, indolent lymphoma and mantle cell lymphoma,' Dr. Mathias Rummel, the study's lead investigator from Justus-Liebig University Hospital in Giessen, Germany, said in an interview.

Although Cephalon is likely to be a chief beneficiary of the data, the study was not sponsored by the biotechnology company but initiated and funded by Rummel's Study Group of Indolent Lymphomas in Germany.

In addition to a superior ability to hold the disease in check, Treanda appeared to have a far better safety profile than CHOP chemotherapy.

The blood toxicity of bendamustine was much lower than CHOP, Rummel said.

There was also a statistically significantly lower incidence of leukocytopenia, or decrease in white blood cells, of 12 percent on Treanda versus 38 percent with CHOP, and more infectious complications with CHOP, Rummel said.

In addition, as seen with previous studies there was no hair loss in Treanda patients. 'Every patient is going to lose his hair when you treat him with CHOP,' Rummel said.

'This randomized trial shows that bendamustine/rituximab improves significantly progression free survival and complete response rates compared with CHOP plus rituximab, while showing a better tolerability profile with no alopecia (hair loss), less hematotoxicity and less toxicities (over) all,' Rummel concluded.

(Reporting by Bill Berkrot, editing by Dave Zimmerman) Keywords: ASH/CEPHALON ([e-mail]; [phone]; Reuters Messaging: [e-mail]) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.