The phase III APHINITY study‘s statistically significant final overall survival (OS) results were released by Roche today. According to the study, people with HER2-positive early-stage breast cancer had a 17% lower chance of dying if they followed a Perjeta-based regimen.
The APHINITY study’s ten-year follow-up results showed that adjuvant Perjeta® (pertuzumab) added to chemotherapy and Herceptin® (trastuzumab) resulted in a clinically significant survival benefit. Notably, the pre-specified subset of patients with lymph node-positive illness showed a 21% lower risk of death.
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,
These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting.
Levi Garraway
After 10 years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival,
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.
Prof. Sibylle Loibl
Key APHINITY Study Results
In contrast to 89.8% of patients treated with Herceptin, chemotherapy, and a placebo, 91.6% of patients treated with the Perjeta-based regimen were still alive at the 10-year period. This suggests that people on Perjeta have a 17% lower chance of dying (hazard ratio [HR]=0.83, p-value=0.044).
A 21% decrease in the risk of death was observed in a particular subset of individuals with lymph node-positive illness (HR=0.79). Additionally, the study supported earlier findings by confirming the previously noted benefit in invasive disease-free survival (HR=0.79). The subset of individuals with node-negative illness, however, showed no improvement.
There were no unexpected or novel safety concerns discovered, and the treatment’s safety profile, including cardiac safety, remained in line with earlier research.
APHINITY Study Details
The global, phase III, randomised, double-blind, placebo-controlled, two-arm study APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial Therapy in Breast Cancer, NCT01358877/BO25126/ BIG 4-11) compares the safety and effectiveness of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy versus Herceptin and chemotherapy as post-surgery (adjuvant) treatment in 4,804 patients with operable, early-stage breast cancer that is positive for the human epidermal growth factor receptor.
The study’s main outcome is invasive disease-free survival, which is the amount of time a patient has after surgery without dying from any cause or experiencing a recurrence of invasive breast cancer (when the cancer spreads into the surrounding breast tissue or returns locally). Overall survival, cardiac and general safety, and health-related quality of life are examples of secondary objectives.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
