Roche announced final survival results from the Phase III CLEOPATRA study, which showed that adding Perjeta to Herceptin and docetaxel chemotherapy extended the lives of people with previously untreated HER2-positive metastatic breast cancer (mBC) by 15.7 months compared to Herceptin and chemotherapy.
"Adding Perjeta to treatment with Herceptin and chemotherapy resulted in the longest survival observed to date in a
clinical study of people with HER2-positive metastatic breast cancer," said Sandra Horning, M.D., Roche’s Chief Medical
Officer and Head, Global Product Development. "The median survival of nearly five years for people who received the
Perjeta regimen is 15.7 months longer than for people who received Herceptin and chemotherapy alone, a magnitude of
improvement we rarely see in clinical trials in advanced cancer."
According to the press release, Perjeta -- in combination with Herceptin and docetaxel chemotherapy -- is approved in the United States and the EU for people with previously untreated HER2-positive mBC. The Perjeta regimen has also been granted accelerated approval as a neoadjuvant treatment (use before surgery) for HER2-positive early breast cancer (eBC) by the U.S. Food and Drug Administration (FDA). An application to update the Marketing Authorization to include this indication has also recently been submitted to the European Medicines Agency.
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