Roche’s breast cancer drug Perjeta (pertuzumab) has shown extended survival benefits in patients with previously untreated HER2-positive metastatic breast cancer.
Results were obtained from the Phase III Cleopatra study, which is a randomised, double-blind and placebo-controlled study.
Perjeta in combination with Herceptin (trastuzumab) and docetaxel chemotherapy, was found to help extend patients’ lives by 15.7 months, compared to Herceptin and chemotherapy.
The drug targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.
Roche chief medical officer and global product development head Dr Sandra Horning said: "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.
"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."
The study assessed the combination of Perjeta, Herceptin and docetaxel chemotherapy against placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive mBC or with HER2-positive mBC that had come back after prior therapy in the adjuvant or neoadjuvant setting.
According to Roche, the primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review committee, while secondary end points comprised OS and safety profile.
In the US and Europe, Perjeta in combination with Herceptin and docetaxel chemotherapy has received approval for the people with previously untreated HER2-positive mBC.
The FDA also granted accelerated approval for Perjeta regimen as a neoadjuvant treatment (use before surgery) for HER2-positive early breast cancer (eBC).
Image: Metastatic Breast Cancer in Pleural Fluid. Photo: courtesy of Ed Uthman from Houston, Texas, US.