Roche announced that the European Commission (EC) has approved the use of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy for the neoadjuvant treatment (use before surgery) of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pCR data.
Every year in Europe nearly 100,000 people are diagnosed with HER2-positive breast cancer, an aggressive type of the disease that is more likely to progress than HER2-negative cancer. Treating people with breast cancer early, before the cancer has spread, may improve the chance of preventing the disease from returning. Neoadjuvant treatment is given before surgery and is aimed at reducing tumour size so it is easier to surgically remove. pCR is achieved when there is no tumour tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. It is a common measure of neoadjuvant treatment effect in breast cancer and it can be assessed more quickly than traditional endpoints in eBC.
The EC approval is based primarily on data from the neoadjuvant Phase II NeoSphere study, which showed that nearly 40% of people receiving the combination of Perjeta, Herceptin and chemotherapy achieved pCR in the affected breast and local lymph nodes compared to 21.5% of people who received Herceptin and taxane chemotherapy alone. The approval was also supported by data from the Phase II neoadjuvant TRYPHAENA study, in which pCR rates ranging from 54.7% to 63.6% were achieved across the three Perjeta-containing study arms. Long-term safety results from the Phase III CLEOPATRA trial in people with previously untreated HER2-positive advanced breast cancer also supported the approval. Data from the ongoing Phase III APHINITY study in the adjuvant (post-surgery) setting will provide additional insights into the broader role of Perjeta in the treatment of HER2-positive eBC.
