Roche’s Perjeta regimen extended the lives of people with an aggressive type of metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced final survival results from the Phase III CLEOPATRA study, which showed that adding Perjeta (pertuzumab) to Herceptin (trastuzumab) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer (mBC) by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months).¹ No new safety signals were observed in the study.¹ These data will be presented today in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2014 congress in Madrid, Spain (Abstract #350O_PR; Sunday, September 28, 4:00 – 5:30 p.m. CEST) and are also featured in the official ESMO Press Briefing.

“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.”

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 Authorisation to include this indication has also recently been submitted to the European Medicines Agency.

1. Swain S. et al. Final overall survival (OS) analysis from the CLEOPATRA study of first-line (1L) pertuzumab (Ptz), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC). European Society for Medical Oncology 2014, abstract #350O_PR