Roche’s supplemental Biologics License Application (sBLA), which was accepted by the FDA, is based on results of the phase III APHINITY study that assessed the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 people with operable HER2-positive eBC.
The study’s primary efficacy endpoint is invasive disease-free survival (iDFS), which in this trial is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment.
Cardiac and overall safety, overall survival, disease-free survival and health-related quality of life were the secondary endpoints.
Perjeta 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.
It avoids the HER2 receptor from combining with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells.
Binding of Perjeta to HER2 could also signal the body’s immune system to destroy the cancer cells.
Roche said the mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places.
The combination of Perjeta and Herceptin is believed to offer a dual blockade of HER signalling pathways, resulting in the prevention of tumour cell growth and survival.
Roche chief medical officer and head of global product development Sandra Horning said: “The goal of treating breast cancer early is to provide people with the best chance for a cure.
“Despite advances in the treatment of this disease, many people treated with the current standard of care still see their cancer return.”
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