Roche's Perjeta-Based Regimen Shows Long-Term Survival Benefit in HER2-Positive Breast Cancer

Roche has unveiled compelling long-term survival data for its Perjeta-based regimen in early-stage HER2-positive breast cancer, reinforcing the treatment's position as a standard of care in the adjuvant setting. The Swiss pharmaceutical giant presented the results from its phase 3 APHINITY study at the 2025 European Society for Medical Oncology Breast Cancer Congress, demonstrating sustained benefits after a decade of follow-up.

Significant Survival Advantage in Long-Term Study

The APHINITY trial, which included 4,804 patients, evaluated a post-surgery regimen of Perjeta (pertuzumab), Herceptin (trastuzumab), and chemotherapy against a control arm of Herceptin, chemotherapy, and placebo. After ten years, the Perjeta-based regimen showed a statistically significant 17% reduction in the risk of death compared to the control group.

Specifically, 91.6% of patients treated with the Perjeta combination were alive at the ten-year mark, compared to 89.8% in the control arm. Dr. Levi Garraway, Genentech's chief medical officer and head of global product development, emphasized that these results "validate the sustained benefits of the Perjeta-based regimen" and "reinforce the regimen's value as a well-established standard-of-care treatment in the curative setting."

Enhanced Benefit for High-Risk Patients

The study revealed an even more pronounced benefit for patients with lymph node-positive disease, who are at higher risk of recurrence. This subgroup experienced a 21% reduction in the risk of death when treated with the Perjeta-based regimen.

Dr. Sibylle Loibl, CEO of the German Breast Group Forschungs and APHINITY study chair, noted that the addition of Perjeta to the standard post-surgical treatment appears "most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence."

Perjeta's Market Position and Future Outlook

Despite the prevalence of Herceptin biosimilars, Perjeta continues to be a strong performer for Roche. In 2024, Perjeta generated approximately $4.3 billion in sales, while Herceptin contributed $1.6 billion. However, the landscape may change as Shanghai Henlius Biotech's Perjeta biosimilar candidate was accepted for FDA review in February 2025.

The pharmaceutical industry is closely watching the evolution of HER2-positive breast cancer treatment. Recently, AstraZeneca and Daiichi Sankyo's antibody-drug conjugate Enhertu, in combination with Perjeta, demonstrated superiority over the standard Perjeta, Herceptin, and chemotherapy regimen in delaying tumor progression or death for patients with newly diagnosed HER2-positive metastatic breast cancer.

As competition intensifies and biosimilars enter the market, Roche's long-term data for the Perjeta-based regimen may play a crucial role in maintaining its position in the HER2-positive breast cancer treatment landscape. Industry analysts project that Roche will become the largest drugmaker by sales in 2025, highlighting the continued importance of its oncology portfolio.