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Adding Pertuzumab to Trastuzumab and Chemotherapy Reduced Risk of Death by 17% in HER2+ Breast Cancer
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Key Takeaways
- The pertuzumab-based regimen significantly reduces the risk of death and recurrence in HER2+ early-stage breast cancer, especially in lymph node-positive patients.
- APHINITY study shows a 17% reduction in death risk and improved overall survival with pertuzumab, trastuzumab, and chemotherapy.
New data reveals that combining pertuzumab with trastuzumab significantly improves survival rates in HER2+ breast cancer patients, reducing death risk by 17%.
Long-term follow-up data show clinically meaningful benefit when combining pertuzumab (Perjeta; Genentech) with trastuzumab (Herceptin; Genentech) and chemotherapy in patients with human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (eBC). According to the phase 3 APHINITY study (NCT01358877), the regimen yielded a 17% reduction in risk of death. The data are to be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress.1
Trastuzumab, pertuzumab binding to breast cancer cells | Image Credit: © LASZLO - stock.adobe.com
“After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Sibylle Loibl, PhD, APHINITY Study Chair, Chair of the German Breast Group (GBG) and the CEO of the GBG Forschungs GmbH, in a news release. “Adding [pertuzumab] to a standard adjuvant treatment is most beneficial for people with HER2+ BC with lymph node-positive disease who are at high risk of recurrence.”2
HER2+ BC is one of the most common HER2 mutations and accounts for about 20% of all BC diagnoses worldwide. It is challenging to treat HER2+ BC due to its aggressiveness, rapid progression, and higher fatality rates than other BC subtypes. In the past, these patients had poor prognoses, but the advent of new medications has significantly improved survival rates to about 90%.3
The pertuzumab-based regimen demonstrated significant benefits in pathological complete response and reducing risk of disease recurrence in early-stage and metastatic settings, leading to its approval in over 120 countries. Compared with trastuzumab and chemotherapy, the pertuzumab-based combination yields nearly double the rate of histological full response in the neoadjuvant setting of eBC. In the adjuvant setting, the combination has been shown to dramatically lower the risk of death or recurrence of invasive disease.2
APHINITY is a randomized, multicenter, double-blind, placebo-controlled comparison of chemotherapy with trastuzumab plus placebo versus chemotherapy with trastuzumab plus pertuzumab as adjuvant therapy in 4804 patients with HER2+ BC. The primary end point was invasive disease-free survival (IDFS), with secondary end points including cardiac and overall safety, overall survival, and health-related quality of life.
Almost all patients treated with the pertuzumab-based regimen (91.6%) were alive at 10 years compared with 89.8% of those treated with trastuzumab, chemotherapy, and placebo (hazard ratio [HR] = 0.83, 95% CI: 0.69-1.00, P-value = .044). A reduction in risk of death (21%) was most prominent in the lymph node-positive disease subgroup (HR = 0.79, 95% CI: 0.64-0.97). The IDFS benefit was maintained from previously reported data, which further validates the trial findings.1,2
The safety profile was favorable and consistent with prior studies. The investigators reported no new or unexpected safety signals.2
“The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,” Liz Frank, Independent Research Advocate, said in a news release. “Scientists and clinicians are working together with the broader goal of improving our understanding of HER2+ breast cancer, improving the quality of life for people living with the disease, and ultimately, helping them to live longer with no disease occurring.”2
