Genentech and Biogen Idec’s Phase III Leukemia Study Meets Endpoint
Genentech and Biogen Idec have announced that a global Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival, as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia compared to chemotherapy alone.
There were no new or unexpected safety signals reported in the study. An independent review of the primary endpoint is being conducted for US regulatory purposes.
REACH is a multi-center, randomized, open-label, international Phase III study that enrolled 552 patients with previously treated CD20-positive chronic lymphocytic leukemia. The study evaluated the efficacy and safety profile of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy versus fludarabine and cyclophosphamide chemotherapy alone.
The primary endpoint was progression-free survival, defined as the length of time from the date of treatment randomization to the time of disease progression, relapse or death from any cause. Secondary endpoints included overall survival, event-free survival, duration of response, response rate and complete response.
Cecil Pickett, president of R&D at Biogen Idec, said: “The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication.”