Roche has reported positive results from the Phase III (APHINITY) clinical trial of perjeta (pertuzumab) in combination with herceptin (trastuzumab) and chemotherapy for the treatment of patients with breast cancer.
The trial was conducted in collaboration with the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS).
Perjeta is being developed to target the HER2 receptor protein that is found outside the cancer cells in HER2-positive patients.
It is designed to inhibit the HER2 receptor from pairing with other HER receptors such as EGFR / HER1, HER3 and HER4 on the surface of cells.
The trial results indicated that the drug has met its primary endpoint, and the adjuvant after surgery treatment resulted in a statistically significant decrease in the risk of recurrence or death when compared to herceptin and chemotherapy alone.
The international, randomised, double-blind, placebo-controlled, two-arm Phase III trial evaluated the efficacy and safety of the combination therapy in 4,805 subjects with operable HER2-positive eBC.
Roche chief medical officer and global product development head Sandra Horning said: “These results from the positive APHINITY study represent an important addition to the body of data for perjeta in the treatment of people with HER2-positive early breast cancer."
The secondary endpoints of the trial were cardiac and overall safety, overall survival, disease-free survival and health-related quality of life.
The safety profile of the perjeta-based regimen was found to be consistent with the previous studies and no new safety signals were identified.
The therapy is currently licenced for before surgery treatment of patients with HER2-positive eBC in more than 75 countries.
Image: Roche facility in Basel, Switzerland. Photo: courtesy of F Hoffmann-La Roche.