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Genentech flashes PhIII progress for prized Rituxan successor

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Genentech provided hints that one of the most important experimental cancer drugs in its pipeline performed well in the first part of a two-stage pivotal study in patients on their initial round of treatment for chronic lymphocytic leukemia (CLL). And the U.S. biotech unit of Roche ($RHHBY) is advancing the second stage of the Phase III trial to show whether its new treatment can trump the benefits of blockbuster Rituxan in first-line CLL patients.

Patients on experimental obinutuzumab, or GA101, and the chemo drug chlorambucil lived "significantly" longer without their disease getting worse than those on the chemo med alone in part one of the study, Genentech said. A futility analysis yielded early evidence that the type 2 CD20-targeting therapy could top Rituxan. And gunning for approvals in first-line CLL, the company is sending the results to European and U.S. regulators.

"The improvement in progression-free survival seen with GA101 is encouraging for people with CLL, a chronic illness of older people for which new treatment options are needed," stated Dr. Hal Barron, medical chief and head of global product development for Roche/Genentech. "GA101 demonstrates our ongoing commitment to the research and development of new medicines for this disease."

In a way, Genentech is competing against itself and holding all the good cards in the development of GA101. Rituxan, the multibillion-dollar drug from Genentech and Biogen Idec ($BIIB), is the standard of care for CLL cases that express CD20. However, the blockbuster loses patent exclusivity in Europe in late 2013, and those developing biosimilar versions of the drug aim to grab market share from Biogen and Roche/Genentech.   

Genentech, which has a deep pipeline of blood-cancer drugs, plans to reveal detailed data from the Phase III study of GA101 in CLL, called "CLL11," at a future medical meeting. Meantime, industry watchers eagerly await word from the FDA on the company's armed antibody drug T-DM1, which could fuel its dominant position in providing treatments for HER2-positive breast cancer.

- here's the release

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