Roche has reported that the pivotal phase III study, CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with MabThera/Rituxan (rituximab), compared to chemotherapy alone. The results were presented at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (US).
Michael Hallek, professor of University of Cologne, Germany, who led the CLL8 trial for the German CLL Study Group (GCLLSG), said: “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. 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% of patients with previously untreated CLL who received MabThera/Rituxan plus FC were alive after more than three years of follow up, as compared to 82.5% 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, as 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.
William Burns, CEO of pharmaceuticals division at Roche, said: “With these new data, MabThera/Rituxan is now proven to offer patients suffering from this incurable disease the very real hope of living longer. It once again illustrates the ongoing potential shown by MabThera/Rituxan in changing the treatment patterns of chronic diseases like CLL.”