Study is Second Positive Phase III Trial of Rituxan Plus Chemotherapy in Most Common Adult Leukemia

Genentech, Inc. (NYSE:DNA) and Biogen Idec (Nasdaq:BIIB) today announced that a global Phase III study of Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL) 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 U.S. regulatory purposes.

Data from the study, REACH, will be submitted for presentation at a future medical meeting. Earlier this year, another European Phase III study, CLL-8, showed a similar treatment combination improved PFS in patients with CLL who had not previously received treatment.

"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”

"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of Research and Development. "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."

About the REACH Study

REACH is a multi-center, randomized, open-label, international Phase III study that enrolled 552 patients with previously treated CD20-positive CLL. 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 PFS, 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.

About Chronic Lymphocytic Leukemia

CLL is the most common type of leukemia in adults. The cancer is a slow-growing type of leukemia in which excess mature B-cells are found in the blood and bone marrow. According to the American Cancer Society, CLL accounts for one-third of all leukemias in the United States.