Genentech, a member of the Roche Group, announced results from Cleopatra, the first randomized Phase 3 study of the investigational HER2-targeted medicine pertuzumab. The study compared the combination of pertuzumab, Herceptin (trastuzumab) and docetaxel chemotherapy to Herceptin and docetaxel alone in people with previously untreated HER2-positive metastatic breast cancer (mBC). People who received pertuzumab in combination with Herceptin and chemotherapy experienced a 38 percent reduction in the risk of their disease worsening or death (progression-free survival, or PFS) (HR=0.62; p-value less than 0.0001). The median PFS improved by 6.1 months from 12.4 months for Herceptin and chemotherapy to 18.5 months for pertuzumab, Herceptin and chemotherapy. Overall survival (OS) data are currently immature, with a trend in favor of the pertuzumab combination.
No new safety signals were observed, and adverse events (AEs) were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. The results will be presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, December 9, 2011 (Abstract #S5-5), and will be featured in the official press program. Data were also published today in the online edition of the New England Journal of Medicine. Genentech has submitted a Biologics License Application for pertuzumab to the U.S. Food and Drug Administration (FDA) for people with previously untreated, HER2-positive mBC, and Roche has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for pertuzumab in the same indication.
“We have been studying the HER2 pathway for 30 years to bring personalized medicines to people with HER2-positive breast cancer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “These results show we may soon improve on the current standard of care, Herceptin plus chemotherapy, to further help people with this advanced form of the disease.”
The mechanisms of action of pertuzumab and Herceptin are believed to complement each other as both bind to the HER2 receptor but on different regions. This is believed to provide a more comprehensive blockade of HER signaling pathways.
Date: December 8, 2011