Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo. Results showed that the risk of death was reduced by 34 percent for people who received Perjeta, Herceptin and chemotherapy, compared to those who received Herceptin and chemotherap (HR=0.66; p=0.0008). At the time of the analysis, median overall survival had not yet been reached in people receiving the Perjeta combination, as more than half of these people continued to survive. Median overall survival was more than three years (37.6 months) for people who received Herceptin and chemotherapy. Based on these data, people receiving Herceptin and chemotherapy in CLEOPATRA have been offered the option to receive Perjeta. No new safety signals were observed in the study.
"This treatment combination with Perjeta is the first to have significantly extended survival compared to Herceptin and chemotherapy in people with previously untreated HER2-positive metastatic breast cancer," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "These data further demonstrate that Perjeta is an important new medicine for people with this aggressive disease."
Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different places on the HER2 receptor.
In June 2012, the U.S. Food and Drug Administration (FDA) approved Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of people with HER2-positive mBC who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, based on the results of the CLEOPATRA study. Perjeta was approved by Swissmedic in August 2012 and in Mexico in September 2012 for the treatment of people with HER2-positive mBC who have not received prior therapy for their metastatic disease. Roche has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Perjeta for people with previously untreated HER2-positive mBC.
These final, confirmatory survival data from the CLEOPATRA study will be presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), Friday, December 7, 2012 (Abstract #P5-18-26, 5-7pm CT, Exhibit Hall A-B) by Dr. Sandra Swain, Medstar Washington Hospital Center.