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Drug combination improves lymphoma survival rates

LOS ANGELES, California (Reuters) -- A combination drug therapy looks to be the first new treatment in 20 years for patients with a deadly form of lymphoma, researchers said Sunday.

Conventional chemotherapy combined with Rituxan, a cloned antibody, significantly improves survival chances for patients with the aggressive form of non-Hodgkin's lymphoma, according to study results presented in San Francisco at a meeting of the American Society of Hematology.

"It is very exciting to find that Rituxan, in combination ... is likely to save the lives of patients with aggressive lymphoma," said Gwen Fyfe, senior director of oncology at Genentech Inc., which co-markets the drug.

With chemotherapy, only about 30-40 percent of patients are cured of the cancer, which attacks the lymph system, spleen and other organs. Without successful treatment the average life expectancy of patients is one to six years.

Non-Hodgkin's lymphomas are a group of related cancers that originate in the lymphatic system, which carries white blood cells called lymphocytes throughout the body. An estimated 50,000 new cases are diagnosed in the United States each year and the numbers are increasing, particularly among the elderly and those infected with HIV.

Interim results from the study of 400 elderly patients, led by Dr. Bertrand Coiffier, head of the department of hematology at Hospices Civils de Lyon in Lyon, France, show that the combination of Rituxan and chemotherapy resulted in a one-year survival rate of 83 percent, compared with a rate of 68 percent for the standard combination of chemotherapy and drugs.

Sixty-nine percent of patients on the combination therapy were free of the disease, compared with 49 percent on just chemotherapy. The rates for complete remission were 76 percent and 60 percent, respectively.

Fyfe cautioned that those rates are likely to drop over time -- the results apply to one year -- but said the fact that more patients responded to the combination therapy "is simply remarkable."

In light of the strong results, Fyfe said Genentech and marketing partner IDEC Pharmaceuticals Inc. have suspended another lymphoma trial, although they are continuing a trial monitoring safety of the combination therapy.

The French investigators said the antibody/chemotherapy combination did not cause additional treatment-related side effects.

Rituxan, which was launched in late 1997, is currently approved for patients with the low-grade form of non-Hodgkin's lymphoma who have failed to benefit from standard therapies or have relapsed after such therapies.

Monoclonal antibodies like Rituxan are derived from a single clone of antibody-producing cells and bind only to one antigen. Rituxan binds specifically to the CD20 antigen, a molecule present on the surface of B cells, a type of white blood cell.

Once bound to the B cells, Rituxan, working with the body's immune system, causes the cancerous cells to destruct.

The drug, which had total third-quarter sales in the United States of $115.5 million, is viewed as having the potential to reach annual sales of $1 billion.

Doctors are already believed to be using Rituxan on an off-label basis -- in higher dosages and for different types of cancer than those for which Rituxan was officially approved. Doctors can prescribe any approved medicine as they wish, so the practice is legal.

Genentech said it plans to submit the latest trial data to the Food and Drug Administration (FDA), but not for several more months.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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OncoLink: Non-Hodgkins Lymphoma
CancerBACUP - Understanding non Hodgkins lymphoma
American Society of Hematology
RituxanŽ - Therapy for Non-Hodgkin's Lymphoma
Genentech, Inc.
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