Roche announces positive results of pivotal Phase III study with pertuzumab in HER2-positive metastatic breast cancer

6.1 month improvement in median progression free survival, from 12.4 to 18.5 months

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from CLEOPATRA, the first randomised Phase III 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=<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 favour of the pertuzumab combination.

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. The results will be presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium December 6-10 (Abstract # S5-5), and were featured in the official press program. Data were published yesterday in the online edition of the New England Journal of Medicine. Roche has submitted a Biologics License Application for pertuzumab to the U.S. Food and Drug Administration (FDA) for people with previously untreated, HER2-positive metastatic breast cancer and a Marketing Authorization Application to the European Medicines Agency (EMA) in the same indication.

“We have been studying the HER2 pathway for 30 years to bring personalised 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.”