Swiss pharmaceutical company Roche has reported final overall survival outcomes from a long-term Phase III trial of Perjeta (pertuzumab) with Herceptin (trastuzumab) and chemotherapy for treating breast cancer.
The randomised APHINITY trial assessed the combination’s efficacy and safety against those of Herceptin and chemotherapy in 4,804 subjects with human epidermal growth factor receptor 2 (HER2) positive early-stage breast cancer.
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Its primary goal was to measure invasive disease-free survival, which the study defines as the time a patient lives with no recurrence of invasive breast cancer or mortality from any cause after the surgery, over ten years.
Results from the study showed a 17% decrease in the mortality risk for the Perjeta-based regimen-treated subjects versus those who received Herceptin, chemotherapy and placebo.
Of the subjects given Perjeta, 91.6% were still alive after ten years, compared with 89.8% in the other group.
The company also reported a 21% decrease in mortality risk in subjects with lymph node-positive disease.
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By GlobalDataPerjeta’s safety profile, including cardiac safety, was found to be consistent with prior studies, without any new safety concerns observed.
In addition, the drug’s previously reported invasive disease-free survival benefit was maintained with a hazard ratio of 0.79, complementing outcomes from previous APHINITY analyses, without any benefits observed in the node-negative subgroup.
Roche global product development head and chief medical officer Levi Garraway said: “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.”
Roche said that its work with BIG and other trial partners had enabled studies such as HERA and APHINITY, which have reportedly led to Perjeta and Herceptin becoming standard-of-care treatments.
The Perjeta-based regimen has so far received approval in more than 120 countries for treating early-stage and metastatic HER2-positive breast cancer.
