CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

Jul 15 2011

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint. The study showed that people with HER2-positive metastatic breast cancer (mBC) who received the combination of two targeted medicines, pertuzumab and Herceptin^® (trastuzumab), plus docetaxel chemotherapy lived significantly longer without their disease getting worse (progression-free survival, PFS) than people who received only Herceptin and docetaxel.

No new safety signals were observed and adverse events were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. Data from CLEOPATRA will be submitted for presentation at an upcoming medical meeting.

Despite significant progress, HER2-positive mBC remains an incurable disease.

"These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalized options for people with this aggressive disease," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We plan to submit the study results for global regulatory approval this year."