Genentech, a member of the Roche Group has announced new results from the Phase II NeoSphere study. The results suggested that Perjeta® (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy given prior to surgery reduced the risk of disease getting worse and increased the time people lived without their cancer returning compared to Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC).
The safety profile of the Perjeta regimen was consistent with that seen in previous studies, and no new safety signals were identified. These data will be presented today at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Dr Luca Gianni, Medical Oncology, San Raffaele Hospital, Scientific Institute (Abstract #505).
In the NeoSphere study, both progression-free survival (PFS) and disease-free survival (DFS) were evaluated at three years. The results suggested that people who received the Perjeta regimen prior to surgery were 31% less likely to experience disease worsening, recurrence or death (PFS HR=0.69; 95% CI, 0.34–1.40) compared to those who received Herceptin and chemotherapy. People treated with the Perjeta regimen were also 40% less likely to experience disease recurrence or death (DFS HR=0.60; 95% CI, 0.28–1.27). People in the NeoSphere study who were treated in the neoadjuvant setting also received a year of adjuvant treatment with Herceptin plus chemotherapy after their surgery. The results of this analysis are descriptive, as the study was not designed to show statistical significance for 3-year PFS and DFS.
"Treating breast cancer early, before it has spread, may help prevent the disease from returning or reaching an advanced stage," said Sandra Horning, chief medical officer and head of Global Product Development. "These new results add to the body of data for Perjeta in the neoadjuvant setting, and we look forward to the Phase III APHINITY study results to better understand the broader impact of Perjeta in the adjuvant treatment of HER2-positive early breast cancer."
The results also suggested that people who achieved pathological complete response (pCR; no tumour tissue detectable at the time of surgery in the affected breast and local lymph nodes) were more likely across all arms of the study to be alive and disease-free at three years (PFS HR=0.54; 95% CI, 0.29–1.00; DFS HR=0.68; 95% CI, 0.36–1.26). It was previously reported that the Perjeta regimen significantly increased the number of people who achieved pCR compared to Herceptin and docetaxel chemotherapy (39.3 vs. 21.5%).
In 2013, the FDA granted accelerated approval of the Perjeta regimen for neoadjuvant treatment in people with high-risk, HER2-positive eBC. A full review of data from the ongoing Phase III APHINITY study will be required for the accelerated approval to be converted to a full approval. APHINITY compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment in people with HER2-positive eBC. Data from APHINITY are expected in 2016.
Roche recently submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for the Perjeta regimen as a neoadjuvant treatment for people with HER2-positive eBC.
