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Roche Cancer Drug Trial Succeeds Two Years Early

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www.ProHealth.com • April 14, 2004


ZURICH, April 13 (Reuters) - A late-stage clinical trial of cancer drug MabThera for treating the relapsed indolent form of non-Hodgkin's lymphoma met its primary goals two years earlier than expected, Roche Holding AG (ROG.VX) said on Tuesday. MabThera, also known as Rituxan, is already the Swiss healthcare group's top-selling drug. Genentech Inc (NYSE:DNA - News) and Biogen Idec (NasdaqNM:BIIB - News) co-market MabThera in the United States.

In the two-part phase III trial, patients were randomly assigned to get MabThera plus chemotherapy or chemotherapy alone as initial treatment, and responding patients received MabThera for two years as maintenance therapy or no further treatment. Analysis showed that "MabThera plus chemotherapy was significantly more effective than chemotherapy alone as initial treatment, and patients subsequently treated with MabThera maintenance for two years had significantly better progression-free survival than those who received no further treatment", a Roche statement said.

Roche's drug division chief, William Burns, noted that more than half of patients with relapsed indolent NHL are treated with chemotherapy alone at present and said the trial confirmed that MabThera should be the standard of care for patients with that form of the disease. An independent panel monitoring the trial data suggested changing the objective of the study to answer the question of whether MabThera maintenance therapy benefits patients receiving MabThera plus chemotherapy as initial treatment, so the trial will be amended in this way, Roche said.

Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45 percent of NHL patients, is a slowly developing but serious cancer of the lymphatic system. MabThera is already indicated as a single-agent treatment for relapsed or refractory indolent NHL and received European approval in March 2002 for treating the aggressive form of NHL in combination with standard chemotherapy.



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