10-Year Survival Rate of 91.6% Achieved in Roche's Phase III APHINITY Study with Pertuzumab for HER2-Positive Early Breast Cancer

On May 13, Roche announced the Phase III APHINITY studyFinal Overall Survival（OS）Results, the study focuses onHER2-Positive Early Breast CancerPatients. Ten-year research results show that the study achieved statistical significance: compared with patients treated with Herceptin, chemotherapy, and placebo,Accept Pertuzumab（Perjeta）、Herceptin(Trastuzumab)And chemotherapy as postoperative(Auxiliary)Patients treated had a 17% reduction in the risk of death.

Screenshot source: Roche official website

APHINITY（NCT01358877/ BO25126/ BIG 4-11）It is a global Phase III, randomized, double-blind, placebo-controlled, two-arm study designed to evaluate the efficacy and safety of pertuzumab combined with Herceptin and chemotherapy as post-surgical (adjuvant) treatment, compared with Herceptin combined with chemotherapy.

The study was conducted in 4,804 patients with HER2-positive early breast cancer who were eligible for surgical treatment. The primary endpoint was invasive disease-free survival, and secondary endpoints included cardiac and overall safety, overall survival, and health-related quality of life.

Results after ten years showed:

• Patients receiving Pertuzumab regimen treatmentThe 10-year survival rate is 91.6%., while patients receiving Herceptin, chemotherapy, and placebo treatmentsThe 10-year survival rate is 89.8%.（Hazard Ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044)。

• In the predefined subgroup of patients with lymph node positivity,The risk of death was reduced by 21%.（HR=0.79，95% CI：0.64-0.97）。

• Previously Reported APHINITY Analysis of Invasive Disease-Free Survival(Primary Endpoint)The benefit was maintained.（HR=0.79，95% CI：0.68-0.92）. No benefit was observed in the lymph node-negative subgroup.

• Safety, including cardiac safety, was consistent with previous studies, and no new or unexpected safety signals were identified.

"After 10 years of observation, the APHINITY trial clearly shows that,Overall survival rates showed significant improvement both statistically and clinically., "APHINITY Study Chair, President of the German Breast Cancer Study Group (GBG), and CEO of GBG Forschungs GmbHProfessor Sibylle LoiblRepresentation."For HER2-positive breast cancer patients with lymph node positivity and a higher risk of recurrence, the addition of pertuzumab to standard adjuvant therapy is most beneficial."

The full results of this study will be presented as a late-breaking abstract at the European Society for Medical Oncology Breast Cancer Congress 2025 on May 15.（LBA）Published in the form of.

Currently, the treatment regimen based on Pertuzumab has been approved in more than 120 countries/regions.For the treatment of early and metastatic HER2-positive breast cancer.In neoadjuvant therapy(Before surgery)In early breast cancer, compared to Herceptin and chemotherapy, the Perjeta-based regimen nearly doubles the pathological complete response rate. Additionally, this combination therapy has also been shown to significantly reduce adjuvant treatment.(Post-surgery)Risk of invasive disease recurrence or death in early breast cancer. In metastatic breast cancer, this combination therapy has shown benefits in untreated patients.(First-line)Unprecedented survival benefits for HER2-positive metastatic breast cancer patients.

Phesgo® is a subcutaneous fixed-dose combination of Perjeta and Herceptin, which has also been approved in more than 120 countries/regions. Compared with the standard intravenous infusion that takes several hours, the subcutaneous administration of Perjeta and Herceptin only takes about eight minutes, which is faster and more flexible.

Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.

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