Study Finds Rituxan Drug Curbs Leukemia

Genentech, Roche’s Rituxan Drug Curbs Leukemia, Study Finds

By David Olmos

Dec. 7 (Bloomberg) -- Genentech Inc. and Roche Holding AG’s drug Rituxan helped patients with a slow-growing form of leukemia keep the blood cancer from worsening in two clinical trials, findings that may change the way the disease is treated, scientists said.

One study of 817 patients newly diagnosed with chronic lymphocytic leukemia found that those given Rituxan combined with chemotherapy had a 41 percent reduction in the risk of death or their cancer progressing when compared with those treated with chemotherapy alone, researchers said during a presentation at the American Society of Hematology meeting, which is being held this weekend in San Francisco.

Chemotherapy drugs have been the standard treatment for chronic lymphocytic leukemia, or CLL, for nearly 50 years. The results of the latest studies make it likely that Rituxan plus chemotherapy will become the new treatment standard for chronic lymphocytic leukemia, said Linda Burns, a blood-cancer specialist at the University of Minnesota in Minneapolis.

“We have two gold-standard studies here,” Burns said during a presentation of the findings. “I would anticipate that this would be practice changing” for physicians.

A second study involving 552 participants found the drug reduced the risk of cancer progression or death by 35 percent for patients who had a relapse of symptoms after chemotherapy.

CLL is a slowly progressing disease in which abnormal white blood cells known as lymphocytes are found in the blood and bone marrow. The median age of diagnosis is age 72, and more than 90,000 people are living with the disease in the U.S., according to a Genentech statement.

Rituxan is already approved for use against non-Hodgkins lymphoma and rheumatoid arthritis. The drug generated sales of $2.3 billion for Genentech and $5.5 billion for Roche, of Basel, Switzerland, in 2007. Biogen Idec Inc, based in Cambridge, Massachusetts, co-markets Rituxan in the U.S.

Regulatory Submission

South San Francisco-based Genentech will ask U.S. regulators to approve Rituxan for patients who are newly diagnosed with CLL or those who have had a relapse of symptoms “as soon as possible,” David Schenkein, senior vice president for clinical hematology and oncology for Genentech, said in an interview.

Both studies, among the largest ever conducted for CLL, found that patients on the Rituxan therapy went about 10 months longer without their tumors growing than those on standard chemotherapy, researchers said.

Neither study provided definitive data on whether patients on the Rituxan therapy lived longer. The studies showed “a trend” toward longer survival, though more studies are needed to answer that question, said Michael Hallek, the lead investigator of one of the studies and a researcher at the University of Cologne in Cologne, Germany, at the meeting.

Roche in July asked European regulators for permission to market the drug, sold under the name MabThera in Europe, as a treatment for leukemia. Roche is seeking to increase sales of the medicine by getting approval for additional uses.

To contact the reporter on this story: David Olmos in San Francisco dolmos@bloomberg.net
Last Updated: December 6, 2008 21:10 EST