Eight-year data from APHINITY study show Roche’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer.- Roche.

Results at 8.4 years median follow-up (101 months) showed the continued benefit of the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), versus Herceptin, chemotherapy and placebo, when given as post-surgery (adjuvant) intravenous (IV) treatment for people with lymph node (LN)-positive, HER2-positive early breast cancer, who are at high risk of recurrence. For patients with lymph node (LN)-positive disease, results showed a 28% reduction in the risk of recurrence or death, corresponding to an absolute benefit at eight years of 4.9% (invasive disease-free survival [iDFS], hazard ratio [HR]=0.72, 95% confidence interval [CI] 0.60-0.87). The safety profile was consistent with previous studies. Full findings were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary (VP6-2022).

Prof. Sibylle Loibl, Chair of the German Breast Group (GBG) and the Chief Executive Officer of the GBG Forschungs GmbH, and APHINITY Study Chair, also commented: “These updated APHINITY data showed further reduction in the risk of cancer returning or death with a pertuzumab-based regimen in patients with LN-positive, HER2-positive early breast cancer, regardless of hormone receptor status. The trend towards a survival benefit was influenced by the LN-positive cohort and additional follow-up is very important to determine possible survival benefit and long-term safety of this regimen.”

The third interim overall survival (OS) analysis of the APHINITY study was conducted after a median follow-up of 8.4 years (101 months), and also included updated results on iDFS and safety. The results showed remarkable outcomes consistent with prior analyses.

After eight years, results showed : i. Fewer deaths were observed with the Perjeta-based regimen (168 [7.0%] versus 202 [8.4%] [HR=0.83; 95% CI: 0.68-1.02]); however, OS data remain immature and statistical significance has not yet been reached. ii. The Perjeta-based regimen continued to reduce the risk of breast cancer recurrence or death versus Herceptin, chemotherapy and placebo, by 23% in the overall study population (iDFS, HR=0.77, 95% CI 0.66-0.91). iii. More people who received post-surgery treatment with the Perjeta-based regimen remained disease-free than those treated with Herceptin, chemotherapy and placebo (88.4% and 85.8% respectively, showing an absolute benefit of 2.6%).iv. The greatest benefit continued to be observed in people at high risk of cancer recurrence, primarily those with LN-positive disease (when the cancer has spread from the breast to the lymph nodes), who are in highest need of more efficacious treatments. In these people there was a 28% reduction in the risk of recurrence or death with the Perjeta-based regimen (HR=0.72; 95% CI 0.60-0.87, showing an absolute benefit of 4.9%: 86.1% versus 81.2%). v. Consistent with the prior analysis, the effect of the Perjeta-based regimen was seen regardless of hormone receptor status. There was a 25% and 18% reduction in the risk of recurrence or death in people with hormone receptor-positive disease and those with hormone receptor-negative disease, respectively (hormone receptor-positive disease: HR=0.75; 95% CI 0.61-0.92 and hormone receptor-negative disease: HR=0.82; 95% CI 0.64-1.06). vi. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified.

Based on the primary analysis of the study in 2017, the clinical value of the Perjeta-based regimen has been recognised by health authorities worldwide. The regimen is approved for the treatment of people with early breast cancer who are at a high risk of recurrence in more than 100 countries, including the United States (US), the European Union (EU) and China. It has also been recognised in multiple international treatment guidelines, including those from the American Society of Clinical Oncology (ASCO), ESMO, the National Comprehensive Cancer Network (NCCN) and St Gallen International Breast Cancer Conference, which recommend it as a standard of care for the post-surgery treatment of people with HER2-positive early breast cancer at high risk of recurrence. More than 500,000 people worldwide who have HER2-positive breast cancer and are at high risk of recurrence have received the Perjeta-based regimen so far.

Patients with either early or metastatic HER2-positive breast cancer may receive Perjeta and Herceptin at the same time in a single under-the-skin (subcutaneous) injection.Phesgo is a fixed-dose combination of Perjeta and Herceptin with hyaluronidase, which offers faster administration under the skin in just minutes, compared to hours with standard IV administration. Phesgo, in combination with IV chemotherapy, has been approved in 73 countries, including the US and in the EU, for the treatment of people with HER2-positive early and metastatic breast cancer.