SHERIDAN, WYOMING – May 27, 2025 – Roche has announced compelling final results from the decade-long APHINITY Phase III clinical trial, demonstrating a significant 17% reduction in the risk of death for patients with HER2-positive early-stage breast cancer who received a Perjeta® (pertuzumab)-based adjuvant therapy. These findings reinforce the strategic role of the Perjeta-based regimen in long-term disease management and will be presented as a late-breaking abstract at the 2025 ESMO Breast Cancer Congress.
Strategic Impact for High-Risk Patient Groups
The APHINITY study highlights even stronger benefits in a key subgroup: patients with lymph node-positive disease experienced a 21% reduction in mortality risk. This outcome strengthens the treatment’s position in clinical practice, especially for those at heightened risk of recurrence.
“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 Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. “These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting.”
Key Clinical Outcomes from APHINITY Trial
The trial enrolled 4,804 patients globally and was designed to compare outcomes of patients receiving Perjeta, Herceptin® (trastuzumab), and chemotherapy against those receiving Herceptin and chemotherapy alone. After 10 years, the results revealed:
- 91.6% survival rate with the Perjeta-based regimen vs. 89.8% with the control group
- Hazard ratio (HR) for overall survival: 0.83 (95% CI: 0.69–1.00; p=0.044)
- In lymph node-positive subgroup: HR=0.79 (95% CI: 0.64–0.97)
- Invasive disease-free survival benefit maintained: HR=0.79 (95% CI: 0.68–0.92)
- No new safety concerns, including cardiac toxicity
“After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival,” said Prof. Sibylle Loibl, Study Chair and CEO of 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.”
Innovation Through Global Collaboration
The APHINITY study is the result of extensive collaboration between Roche, the Breast International Group (BIG), Frontier Science Foundation, and Institut Jules Bordet Clinical Trials Support Unit. According to Liz Frank, Independent Research Advocate, “The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings.”
These efforts have shaped a globally recognized standard of care that now supports more personalized and durable outcomes for patients with HER2-positive breast cancer.
Broader Industry Implications and Future Outlook
The Perjeta-based regimen is already approved in over 120 countries for both early and metastatic HER2-positive breast cancer. In the neoadjuvant setting, it has nearly doubled pathological complete response rates, while in the adjuvant setting, it has significantly reduced recurrence risk.
Furthermore, the subcutaneous version, Phesgo®, allows administration in about eight minutes and is now authorized for use in non-clinical settings, potentially reducing hospital burden and enhancing patient convenience.
Roche’s commitment to HER2-positive breast cancer spans more than three decades, with ongoing efforts to develop biomarker-driven solutions across various cancer subtypes. This milestone solidifies the company’s leadership in oncology innovation, supporting both clinical outcomes and broader healthcare system efficiencies.
Learn more at www.roche.com.