Rituxan improves patients with previously untreated CLL, shows Phase III study CLL8

Dec 10 2009

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with Rituxan (rituximab) compared to chemotherapy alone.

"Treatment with rituximab in the CLL8 randomized study has shown for the first time that a specific first-line treatment for CLL could improve overall survival," said Professor Michael Hallek, University of Cologne, Germany, who led the CLL8 trial for the German CLL Study Group (GCLLSG). "The results support the recommendation to use fludarabine, cyclophosphamide and rituximab (FCR) as standard therapy in physically fit patients with CLL."

New data from the Phase III CLL8 study showed that 84.1 percent of patients with previously untreated CLL who received Rituxan plus FC were alive after more than three years of follow up compared to 79.0 percent of patients who received FC alone>

The results of the CLL8 trial come on the heels of the recent Health Canada approval of Rituxan in combination with chemotherapy (fludarabine and cyclophosphamide (FC)) for use in patients with previously untreated chronic B-cell lymphocytic leukemia (Binet stage B or C).

"The CLL8 findings will make a great impact on the treatment of Canadian patients with CLL. The study establishes that FCR is a standard first-line treatment for fit patients with CLL," said Dr. Christine Chen, hematologist, Princess Margaret Hospital and Assistant Professor, University of Toronto.

"From a patient's perspective, this is the best news that has emerged in CLL. This data demonstrates overall survival which means improved quality of life and extension of life for Canadian patients like myself," said Elizabeth Locatelli, CLL patient and Executive Director of the CLL Patient Advocacy Group.