Genentech, Inc and Biogen Idec announced that two global phase-III studies in chronic lymphocytic leukaemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone. No new safety signals were observed in either of these studies and the safety profile was consistent with previous experience with Rituxan. Results from both studies were featured today during a press briefing at the 50th Annual Meeting of the American Society of Haematology (ASH) in San Francisco.

"These are among the largest studies ever conducted in chronic lymphocytic leukaemia and are significant for patients with newly diagnosed or relapsed disease," said David Schenkein, Genentech's senior vice president, Clinical Oncology and Haematology. "These data show that adding Rituxan to chemotherapy improved both progression-free survival and reduced patients' tumour burden."

In CLL8, patients who received Rituxan plus chemotherapy first-line had a 69 per cent improvement in PFS compared to patients receiving chemotherapy alone (based on a hazard ratio of 0.59; p<0.0001). The improvement in PFS can also be referred to as a 41 percent reduction in the risk of cancer progression or death. Patients who received Rituxan plus chemotherapy had a median PFS of 42.8 months compared to 32.3 months for those who received chemotherapy alone.

In REACH, patients who received Rituxan plus chemotherapy second-line experienced a 54 per cent improvement in PFS compared to patients receiving chemotherapy alone (based on a hazard ratio of 0.65; p=0.0002) as assessed by the treating physicians in the study (investigator-assessed). The improvement in PFS can also be referred to as a 35 percent reduction in the risk of cancer progression or death. Patients who received Rituxan plus chemotherapy had a median PFS of 30.6 months compared to 20.6 months for those who received chemotherapy alone.

An independent review of the PFS primary endpoint for REACH is expected to be complete early next year for US regulatory purposes.

"Adding Rituxan to chemotherapy may be an additional option beyond chemotherapy alone for the more than 90,000 patients living with this incurable disease," said Cecil Pickett, Biogen Idec's president of Research and Development. "We plan to work with Genentech to submit the data from both CLL8 and REACH to the FDA for potential new indications for Rituxan in first- and second-line CLL."

Rituxan is a therapeutic antibody that binds to a particular protein, the CD20 antigen found on the surface of malignant cells as well as normal B-cells.

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