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news.Genentech and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia, CLL8 and Reach, showed Rituxan plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival, when compared to chemotherapy alone.
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No new safety signals were observed in either of these studies and the safety profile was consistent with previous experience with Rituxan, the company said.
In CLL8, patients who received Rituxan plus chemotherapy first-line had a 69% improvement in progression-free survival (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% 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.
According to the company, the overall response rate in patients receiving Rituxan plus chemotherapy second-line was 70% compared to 58% in those receiving chemotherapy alone. Complete response was achieved in 24% of patients compared to 13%, respectively.
In Reach, patients who received Rituxan plus chemotherapy second-line experienced a 54% 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. The improvement in PFS can also be referred to as a 35% 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 in early 2009 for US regulatory purposes.
David Schenkein, senior vice president of clinical oncology and hematology at Genentech, said: These are among the largest studies ever conducted in chronic lymphocytic leukemia and are significant for patients with newly diagnosed or relapsed disease. These data show that adding Rituxan to chemotherapy improved both PFS and reduced patients’ tumor burden.