Genentech announces final overall survival results from APHINITY study

Genentech, a member of the Roche (RHHBY) Group, the Breast International Group, Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced statistically significant final overall survival results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta, Herceptin and chemotherapy for a year as post-surgery treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo. A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease. The previously reported invasive disease-free survival benefit was maintained, strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified. Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress. The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer.