Roche Reports Positive Results In Breast Cancer Study
Roche Holding AG (ROG.VX) Thursday said the results of its pivotal Phase III study with pertuzumab in HER2-positive metastatic breast cancer were positive, with a 6.1 month improvement in median progression free survival, from 12.4 months to 18.5 months.
MAIN FACTS:
- Roche 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 for people with previously untreated, HER2-positive metastatic breast cancer and a Marketing Authorization Application to the European Medicines Agency in the same indication.
-Zurich Bureau, Dow Jones Newswires, +41 43 443 80 47; zurichdjnews@dowjones.com
