
Ten-year APHINITY data show Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer- Roche
Roche, the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) 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 (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044).
- A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97).
- The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), 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, 15 May at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress.
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta (pertuzumab) plus Herceptin (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer.
The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life.
"Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting.”
"After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY Study Chairwoman, and of the German Breast Group (GBG) and the Chief Executive Officer of the GBG Forschungs GmbH. “Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph-node positive disease who are at high risk of recurrence.”
“The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,” said Liz Frank, Independent Research Advocate, Metastatic Breast Cancer Alliance “Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring.”