The Aphinity phase III, randomised, double-blind, placebo-controlled and two-arm study assessed the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as an adjuvant therapy in 4,805 people with operable HER2-positive eBC.
Perjeta is a medicine that focuses on HER2 receptor, which is a protein that can be observed on the outside of multiple normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.
The company has specifically designed Perjeta to prevent the HER2 receptor from pairing with other HER receptors on the surface of cells, which is expected to enhance tumour growth and survival.
The combination of Perjeta, Herceptin and chemotherapy secured licence as a neoadjuvant treatment for people with HER2-positive eBC in around 75 countries, after approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
Currently, the regimen is provided in the US under the FDA accelerated approval programme.
Roche global product development head and chief medical officer 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.
“We look forward to discussing these adjuvant results with global regulatory authorities.”
Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.