Rituxan plus chemo boosts PFS in Ph III CLL trials

US biotechnology firms Genentech and Biogen Idec says that results from two global Phase III studies in chronic lymphocytic leukemia 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, when compared to chemotherapy alone.

Results from the studies were presented at the 50th annual meeting of the American Society of Hematology in San Francisco. In the CLL8 study, patients who received Rituxan plus chemotherapy first-line had a 69% improvement in PFS compared to those given chemotherapy alone (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.

In the REACH trial, patients who received Rituxan plus chemotherapy second-line experienced a 54% improvement in PFS compared to those getting chemotherapy alone (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% 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 given chemotherapy alone.