Positive new data on Perjeta-based regimen

The Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) today announced positive results from the Phase III APHINITY study, Swiss pharma giant Roche (ROG: SIX) announced this morning.

The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Roche drugs Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone. The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, and no new safety signals were identified. Full results from the APHINITY trial will be presented at an upcoming medical meeting in 2017.

The study data has been much anticipated, as analysts have estimated that sales of Herceptin and Perjeta portfolio could reach $9 billion by 2021. Roche shares surged as much as 6.9% to 262.90 Swiss francs in early Zurich trading following the announcement. Herceptin is losing patent protection, exposing it to competition from biosimilar versions. Mylan and Biocon may introduce their biosimilar in Europe this year.

“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,” said Sandra Horning, chief medical officer and head of global product development at Roche, adding: “We look forward to discussing these adjuvant results with global regulatory authorities.”