Phase III Study Showed Rituxan in Combination with Chemotherapy Improved Progression-Free Survival in Patients with Relapsed CLL
Study is Second Positive Phase III Trial of Rituxan Plus Chemotherapy in Most Common Adult Leukemia
Genentech, Inc. and Biogen Idec 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."
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