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Pertuzumab meets Phase III endpoint

July 16, 2011 12:37 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said IV pertuzumab plus Herceptin trastuzumab and docetaxel met the primary endpoint of progression-free survival (PFS) vs. Herceptin plus docetaxel alone in the Phase III CLEOPATRA trial to treat HER2-positive metastatic breast cancer. Genentech said it plans to submit the results for global regulatory approval this year, but did not disclose details. The double-blind, international trial enrolled 808 previously untreated HER2-positive breast cancer patients. Pertuzumab is a mAb HER dimerization inhibitor that prevents HER2 from binding to other HER receptors ( HER1/EGF, HER3 and HER4). ...