Roche presents pivotal phase-III study of CLL8 at ASH 2009

Roche announced at the 51st Meeting of the American Society of Haematology (ASH) in New Orleans, LA (USA) that the pivotal phase-III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukaemia (CLL) survived their disease longer when treated with MabThera/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 87.2 per cent of patients with previously untreated CLL who received MabThera/Rituxan plus FC were alive after more than three years of follow up compared to 82.5 per cent of patients who received FC alone (p=0.012). The median survival has not yet been reached. After more than three years of follow up, patients who received MabThera/Rituxan plus FC had a median progression-free survival (PFS) of 51.8 months compared to 32.8 months for those who received FC alone. No new safety signals were observed in CLL8 and safety was consistent with previous MabThera/Rituxan experience. “With these new data, MabThera/Rituxan is now proven to offer patients suffering from this incurable disease the very real hope of living longer,” said William M Burns, CEO of Roche’s Pharmaceuticals Division. “It once again illustrates the ongoing potential shown by MabThera/Rituxan in changing the treatment patterns of chronic diseases like CLL.” The CLL8 study is an international study conducted by the German CLL Study Group and Professor Michael Hallek (Cologne, Germany) in collaboration with Roche. MabThera/Rituxan is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells.